Grasshopper: A Novel Clinical Dashboard for Radiologists
The primary goal of this project is to evaluate differences in radiology reporting specificity when radiologists use a novel dashboard that surfaces pertinent clinical information at the time of image interpretation. Secondary goals include the evaluation of downstream clinical impact of reporting specificity, including but not limited to decreased utilization of prescription medications and follow-up imaging.
Investigator: Arasu, Vignesh
Funder: TPMG Delivery Science Projects Program
Predictive Power of Quantitative FIT for Colorectal Cancer Screening: QUANTI-FI Study
This study will evaluate the performance characteristics of FIT for screening colorectal cancer and advanced adenomas at varying fecal hemoglobin concentration levels in an asymptomatic, average-risk population. It also will evaluate the predictive role of fecal hemoglobin concentration among subjects with two negative FITs for the subsequent risk of CRC and advanced neoplasia.
Investigator: Lee, Jeffrey
Funder: Polymedco, LLC.
Personalizing Post-Polypectomy Surveillance for Colorectal Cancer Prevention
Despite strong guidance supporting colorectal cancer screening initiation at age 45-50, relatively little is known about what to do for the subsequent 30+ years after screening. The goals of this proposal are to develop and internally validate a clinical (e.g., age, sex, body mass index, family history of colorectal cancer) and endoscopic (e.g., polyp findings) risk score to predict advanced neoplasia after screening; and determine the added value of incorporating a polygenic risk score to this model; validate the performance of the comprehensive risk model using an independent dataset with complete genetic data, and prior screening and clinicopathologic data; identify the optimal strategy for surveillance using information from Aims 1-2 by modeling within the established microsimulation model; and engage key stakeholders (i.e., patients, providers, and healthcare administrators) of the model and elicit their willingness on implementing this tool in clinical practice.
Investigator: Lee, Jeffrey
Funder: National Cancer Institute
Risk of Pediatric and Adolescent Cancer Associated with Medical Imaging — Extension Study
This study is an extension of the Risk of Pediatric and Adolescent Cancer Associated with Medical Imaging (RIC). Our aims are to evaluate patterns of medical imaging and associated radiation exposure in children and adults and to determine the risk of pediatric cancers associated with pediatric exposure to medical imaging, focusing on leukemia and including children born in the health system.
Investigator: Li, De-Kun; Kwan, Marilyn
Funder: University of California, San Francisco (UCSF)
Optimizing Prostate Biopsy in Men with Mildly Elevated PSA Levels or Prior Negative Biopsies
This study will examine whether, in biopsy-naive men with mildly elevated PSA levels (less than or equal to 10 ng/ml) or men with a prior negative biopsy, use of the KP Prostate Cancer Risk Calculator improves detection of high-grade cancer while reducing the number of men with negative biopsies or low-grade, indolent cancer compared to current practice. This project will involve KPNC and KPSC. Some additional secondary reflex tests are commonly used in the evaluation of these patients. Our calculator will be incorporated into their workflow to determine the relative merit of these secondary tests.
Investigator: Presti, Joseph
Funder: Garfield Memorial Fund
Promoting Equity of Cancer Screening and Follow-up for Lung Cancer
This research will elucidate factors that contribute to lung cancer disparities between rural and urban areas and provide contextual information for future interventions and policies. Our specific aims are to: characterize the delivery of evidence-based interventions for lung cancer prevention and early detection, comparing rural to urban areas, by assessing differences in use of smoking cessation interventions and lung cancer screening at multiple levels of influences; identify potentially modifiable care gaps across the lung cancer screening continuum, including risk assessment and timely treatment, by examining patients who died of lung cancer relative to patients who are alive by rural-urban status; and evaluate similarities and differences in the barriers and promoters to delivery of evidence-based intervention across the lung cancer screening continuum (smoking cessation, shared decision-making, screening, and treatment) in the rural and urban contexts.
Investigator: Sakoda, Lori
Funder: National Cancer Institute
Long-Term Trajectories of Accelerated Biological Aging and Functional Decline Associated with Breast Cancer and its Treatment
We combine three decades of clinical, self-reported, and physiological data from the Women’s Health Initiative to characterize long-term trajectories of physical function in breast cancer survivors and test whether they are modified by intensity of cancer treatments; test whether breast cancer and its treatments increase the rate of epigenetic aging and whether the rate of epigenetic aging continues to accelerate after treatment; and examine the relationship between the rate of epigenetic aging and functional decline and test whether it differs between breast cancer survivors and usual aging controls.
Investigator: Feliciano, Elizabeth
Funder: National Cancer Institute
Body composition and breast cancer survival: immune and metabolic biomarkers in breast tumors – Disparities Supplement
This is a supplement with the long-term goal to reduce the disproportionate burden of breast cancer mortality experienced by non-Hispanic black (NHB) women by understanding the role of a key, modifiable risk factor: excess adiposity.
Investigator: Feliciano, Elizabeth
Funder: National Cancer Institute
Crossing the Quality Chasm for Men under age 55 (CQC55)
The goal of this research is to improve hypertension control, diabetes control, and colorectal cancer screening rates among younger men within KPNC. We will start by conducting focus groups with Black, Filipino, and Latino men aged 40-55 to identify barriers and facilitators to chronic disease management and age-appropriate cancer screening. During years 3 and 4, we will use focus group findings to develop multi-modal tailored messaging strategies, or physician and staff communication training. We will evaluate these interventions in trials, assessing the impact on HTN control, T2DM control, and CRC screening rates among younger Black, Filipino, and Latino men.
Investigator: Levin, Theodore
Funder: TPMG Physician Researcher Program
Addressing Disparities in Outcomes of Screening for Colorectal Cancer in Community-Based Settings
This study will evaluate the colorectal cancer screening continuum — tests, screening quality, follow-up care, and health outcomes — over a 20-year time period that covers before, during, and after implementation of an organized colorectal cancer screening at KPNC and KPSC. We will examine receipt and quality of screening by race and ethnicity as well as trends in colorectal cancer screening outcomes by race and ethnicity. We will also use microsimulation modeling to estimate the relative contribution of screening process care gaps on racial and ethnic disparities in colorectal cancer incidence and mortality in various populations.
Investigator: Corley, Douglas
Funder: National Cancer Institute
Lung cancer in older adults: Treatment experience through the patient’s lens (Lens Study)
This multisite prospective cohort study will characterize changes in patient-centered outcomes including function, cognition, and quality of life among older adults with advanced non-small cell lung cancer receiving chemotherapy, immunotherapy, and/or targeted therapy.
Investigator: Wong, Melisa
Funder: National Institute on Aging
Improving decision making for older adults with cancer: A feasibility pilot study
This is a pilot cluster randomized controlled trial to determine the feasibility and acceptability of training medical oncologists to use the Best Case/Worst Case-Geriatric Oncology communication tool in clinical practice with older adults with cancer (NCT05374304).
Investigator: Wong, Melisa
Funder: National Institute on Aging
Loneliness, isolation and associations with cancer and factors predictive of cancer-specific mortality
In 2020, the Kaiser Permanente Research Biobank collected survey data on the effects of the pandemic, including questions on loneliness, living situation, and changes in social contact. We propose to examine these changes in KP members with and without cancer and their influence on rates of cancer diagnosis and factors predictive of cancer survival (stage at diagnosis, health behaviors, heart health, and treatment). Evaluation of these associations will be critical to understanding the influence of social isolation and loneliness on treatment and health in cancer patients.
Investigator: Kroenke, Candyce
Funder: Northern California Community Benefit Programs
Empowering Latinas to Obtain Guideline-Concordant Breast Cancer Screenings
This project will compare the effects of 2 intervention approaches (empowerment+navigation, education+navigation) and underlying mechanisms on guideline concordant breast cancer screening among non-adherent Latinas. We will also compare the effects of the 2 intervention approaches and underlying mechanisms on guideline concordant breast cancer screening among screening-eligible network members of non-adherent Latinas. Lastly, we will examine barriers and facilitators to non-adherent Latinas’ implementation of breast cancer promotion through the empowerment+navigation approach.
Investigator: Kroenke, Candyce
Funder: National Cancer Institute
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
This Bayesian, two-stage, response-adaptive, dose-ranging trial of aerobic exercise during chemotherapy will include 219 stage II-III colon cancer survivors recruited from three diverse racial, and geographic regions (Baton Rouge, LA; Boston, MA; Oakland, CA). In stage 1 of the study, patients are randomized equally to 1 of 5 groups: attention control (stretching) or one of four doses of moderate-intensity aerobic exercise at 75 min/wk, 150 min/wk, 225 min/wk, or 300 min/wk. In stage 2 of the study (starting after 33% of subjects are enrolled), randomization probabilities will be optimized, contingent upon stage 1 efficacy (measured by chemotherapy toxicities and relative dose intensity) and feasibility (measured by exercise adherence) using a longitudinal model to maximize the use of incomplete data, predictive probabilities to guide decisions, and a dose-response model to borrow information across adjacent doses.
Investigator: Caan, Bette
Funder: National Cancer Institute
Association between pre-diagnosis hepatic fat infiltration and risk of liver metastasis and mortality in a large cohort of stage I-III colorectal cancer survivors
The first aims of this study are to radiologically confirm and classify liver metastasis according to size, location and number using CT scans obtained post-diagnosis during follow-up and to confirm and identify previously undetected NAFLD/NASH cases and assess degree of hepatic fat infiltration using CT-scans obtained at the time of diagnosis/ cancer workup. We will then assess whether independent of body fatness and prognostic factors pre-existing NAFLD and NASH is associated with higher risk of liver metastasis and CRC mortality and associations are stronger among NAFLD patients with higher degree of hepatic fat infiltration. We will also assess whether observed associations are modified by co-morbidities related to dysregulated insulin and lipid metabolism (e.g., history of diabetes, cardiovascular disease, visceral obesity, sarcopenia).
Investigator: Caan, Bette
Funder: National Cancer Institute
Understanding the role of adipose tissue distribution and adipokine-related RNA expression in the tumor microenvironment on breast cancer outcomes in a racially and ethnically diverse sample
We will test the central hypothesis that adipose tissue depots (visceral vs. subcutaneous), measured using computed tomography scans, have differing associations with adipokine and adipokine receptor gene expression profiles and related gene signatures in the breast tumor microenvironment, which can be used to develop outcome predictive models. This study will (1) Examine whether adipose tissue distribution impacts cell type-specific RNA expression profiles of leptin, adiponectin, and their receptors in breast tumors and the adjacent breast TME; (2) Define associations of these RNA expression profiles with breast tumor clinicopathology; and (3) Examine whether these RNA expression profiles predict breast cancer recurrence and mortality.
Investigator: Feliciano, Elizabeth
Funder: National Cancer Institute
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4)
Phase 3 trial will evaluate the efficacy of CP101 treatment relative to placebo in adults with previously treated recurrent Clostridioides difficile infection (CDI) and evaluate the safety and tolerability of CP101 treatment compared to placebo in adults with previously treated recurrent CDI.
Investigator: Levin, Theodore
Funder: Finch Research and Development, LLC
Patterns, determinants, and outcomes of guideline-recommended imaging surveillance after surgical resection of early-stage lung cancer
High-quality evidence is limited on the utilization and outcomes of imaging surveillance after definitive surgery for early-stage lung cancer. This study examines patterns and factors associated with guideline-recommended imaging surveillance of lung cancer survivors, in addition to rates of new or recurrent lung cancer and mortality following surgical resection, before and after the implementation of a patient tracking system designed to support imaging surveillance.
Investigator: Sakoda, Lori
Funder: KP National Office of Community Health
Improving Shared Decision Making for Prostate Cancer Screening
To create an optimized E-visit by engaging with member stakeholders; and implement a randomized study in select facilities with a revised E-visit that follows a personalized-medicine approach and compares it to the recently activated E-visit.
Investigator: Presti, Joseph
Funder: TPMG Delivery Science Projects Program
Develop and Validate Novel Body Composition Scores to Predict Survival in Breast Cancer Patients
Researchers have typically investigated how each body compartment may be individually associated with poor survival and other cancer outcomes. This ignores synergistic effects of adipose tissue and muscle on inflammation, oxidative stress, insulin resistance, and chemotherapy dosing, which collectively influence cancer prognosis. We aim to develop and validate novel composite scores of body compositions to predict breast cancer survival.
Investigator: Cheng, En
Funder: Section Pilot Grants
Assess Inflammatory Potential of Diet Among Breast Cancer Patients: Novel Index and Short-Form Questionnaire
Inflammation impacts cancer progression via stimulating tumor proliferation, migration, and angiogenesis. As a key regulator of inflammation, post-diagnosis diet strongly influences risk of breast cancer recurrence and mortality. We propose to develop an inflammatory dietary index for breast cancer patients that predicts canonical plasma inflammatory biomarkers. We will also design a brief inflammatory dietary questionnaire as a feasible dietary screener for clinical use.
Investigator: Cheng, En
Funder: The Permanente Medical Group
Identifying Barriers to Lung Cancer Screening among Asian Americans
This study will identify key barriers to lung cancer screening as well as develop tailored strategies and materials to increase the uptake of lung cancer screening and smoking cessation services among Asian Americans.
Investigator: Sakoda, Lori
Funder: Tobacco-Related Disease Research Program
Comparison of Survival Rates Across Racial/Ethnic Groups Among Young Adults Diagnosed with Early-Onset Colorectal Cancer in a Large, Community-Based Population.
This study will examine racial differences in overall survival among young adults 50 years of age diagnosed with early-onset colorectal cancer in a large, community- based, fully insured population with access to complete primary and specialty care to identify differences in risk factors, access to care, and treatment effectiveness and adherence.
Investigator: Lee, Jeffrey
Funder: Genentech, Inc.
COmprehensive risk Model for Predicting Advanced neoplasia on Surveillance Study (COMPASS)
The goals of this project are to develop and validate a colorectal neoplasia risk prediction model among average-risk patients who underwent a baseline colonoscopy; estimate the risk of advanced neoplasia among patients with newly diagnosed Lynch Syndrome; and develop and validate a colorectal neoplasia risk prediction model among patients with newly diagnosed Lynch Syndrome.
Investigator: Lee, Jeffrey
Funder: Janssen Pharmaceuticals, Inc.
What Factors Affect Time to Surgery for Lung Cancer and Moderate its Associations with Patient Outcomes
This study will determine factors that influence time to surgery and its associations with outcomes in patients with early-stage non-small cell lung cancer.
Investigator: Sakoda, Lori
Funder: TPMG Delivery Science Projects Program
Utilization and Impact of Extended-Interval Dosing of Immunotherapy on Outcomes in Patients with Locally Advanced NSCLC
This study will evaluate the utilization and dosing of durvalumab and associations with treatment outcomes among patients with unresectable stage III non-small cell lung cancer in an integrated health care system.
Investigator: Sakoda, Lori
Funder: AstraZeneca PLC
Multilevel Determinants of Racial/Ethnic Disparities in Lung Cancer Screening Utilization
Lung cancer screening has been underutilized nationally to date, with growing evidence suggesting that screening rates differ by race. This research aims to identify multilevel factors that influence disparities in utilization of lung cancer screening from eligibility determination to screening initiation.
Investigator: Sakoda, Lori
Funder: National Cancer Institute
Long-term effectiveness of BPH/LUTS pharmacological therapies and using machine learning based predictive analytics to tailor treatment
This project will compare the effectiveness of pharmacological therapy for benign prostatic hyperplasia/lower urinary tract symptoms in preventing long-term disease progression and will develop and validate predictive models using demographic, clinical, and laboratory data available at the time of benign prostatic hyperplasia/lower urinary tract symptoms diagnosis to identify patients at increased risk of long-term disease progression.
Investigator: Van Den Eeden, Stephen
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Characterizing the Risk of Chemotherapy Side Effects Based on Epigenetic Age and Modification by Resistance Training Intervention
This study is investigating whether an individual’s epigenetic age — a molecular marker of biological age — at the start of chemotherapy is associated with chemotoxicity in patients receiving treatment for colon cancer and whether resistance training during chemotherapy attenuates that association. We will also investigate if chemotherapy changes these patients’ epigenetic age and whether resistance training attenuates those changes.
Investigator: Caan, Bette
Funder: National Cancer Institute
Ms. LILAC: Muscle Mass in the Life and Longevity After Cancer (LILAC) Study
In WHI, we use the LILAC study and the Long Life Study 2 to collect D-3 creatine to measure muscle mass in older women who are cancer survivors and a matched control group of older women who have not had cancer. Specifically, we will develop age-standardized percentile curves to characterize the distribution of D-3 muscle mass in the cancer survivor and control groups; examine whether the relationship between muscle mass, physical function, and functional decline differs in cancer survivors and controls by assessing the cross-sectional relationship between muscle mass and physical function; the longitudinal relationship between muscle mass and functional decline; and use machine learning methods to create multivariate risk-prediction algorithms to detect low muscle mass in the cancer survivor and control groups.
Investigator: Caan, Bette
Funder: National Cancer Institute
CANcer Cachexia Action Network/CANCAN
This study will include 1500 patients with advanced lung, pancreatic, or colorectal cancer at high risk of cachexia for detailed measurement via biospecimen collection, remote monitoring, questionnaire, and medical record review. The aims are to: identify distinct cachexia subtypes with data-driven clustering; operationalize cachexia subtype definitions, understand their severity, and examine how each subtype is associated with time to death, functional decline, and/or treatment tolerance.; inform treatment decisions for patients likely to progress to cachexia; and validate mechanistic hypotheses and biomarkers developed in related CanCan Projects.
Investigator: Caan, Bette
Funder: Cancer Research UK
Precision Prostate Cancer Screening with Genetically Adjusted Prostate-Specific Antigen Levels
This is a project more comprehensively determine the genetic factors associated with PSA levels, and to develop and apply prediction models for PCa outcomes based on genetically-adjusted PSA levels throughout life, by executing the following specific aims. This will be a multi-site and Multiple PI study that seeks to assess these questions in the GERA, PCPT, USC, UCSF and other cohorts.
Investigator: Van Den Eeden, Stephen
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Comparative Effectiveness of Pretreatment Lung Cancer Nodal Staging
The proposed project will determine whether a guideline-recommended nodal staging strategy is superior to a guideline-discordant nodal staging strategy, and whether a validated risk-based nodal staging strategy that reduces unnecessary biopsies is an equivalent alternative to a guideline-recommended nodal staging strategy in terms of patient outcomes and costs.
Investigator: Sakoda, Lori
Funder: National Cancer Institute
Pyroaeromycoses: fundamental discovery and modeling in an unexplored phenomenon
We are examining the risk from the pyroaeromyobiome from a public health perspective. In particular, our goals are to determine: the association between exposure to wildfire smoke and mycoses diagnose; the mechanisms of fungal biota acquisition, maintenance and dispersal in wildfire smoke; the concentration and composition of microbes is aerosolized into smoke columns by wildland fire; whether microbes aerosolized in wildland fire smoke are viable, and under what conditions; the presence of Cryptococcus gattii presence pre/post fire in endemic zones; and how mammalian (mouse) models respond to fungal pathogens in smoke. We are working with researchers at the University of Idaho and the University of Florida.
Investigator: Van Den Eeden, Stephen
A Prospective Study to Establish a New Onset Diabetes (NOD) Cohort
In this study we are estimating the risk of pancreatic ductal adenocarcinoma among individuals NOD (New Onset Diabetes) Protocol defined hyperglycemia by study status (enrolled, not enrolled, not recruited). We will also participate in a national multi-site effort to build a biorepository that will be used to develop and/or test biomarkers for early detection of pancreatic cancer.
Investigator: Van Den Eeden, Stephen
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Comparative Effectiveness Trial of Non-invasive vs. Invasive Strategies (FIT vs Colonoscopy) for Older Adults with a History of Pre-neoplastic Colon Polyps
This comparative effectiveness trial will evaluate detection of significant neoplasia between the strategies of low threshold annual FIT vs. colonoscopy for older adults with a history of colon polyps. We will investigate whether the FIT strategy is non-inferior to colonoscopy in detecting CRC and advanced colorectal neoplasia over 5 years of follow-up and whether fewer colonoscopies are needed to detect CRC using FIT vs. colonoscopy. We will also compare complication rates and patient experience between the FIT and colonoscopy strategies to see whether those in the FIT strategy will have less complications compared to the colonoscopy strategy and whether the FIT strategy will be more convenient and tolerable compared to the colonoscopy strategy.
Investigator: Levin, Theodore
Funder: Patient-Centered Outcomes Research Institute
Rates and Risk Factors of Post-Colonoscopy Colorectal Cancer in a Large, United States Population-based Cohort Study
Colorectal cancer (CRC) is the third leading cause of cancer death in the United States. Colonoscopy can reduce CRC incidence and deaths through removal of precancerous adenomatous polyps (adenomas) and detection of cancer at an earlier, more treatable stage. However, some patients develop CRC after a colonoscopy in which no cancer is diagnosed. The World Endoscopy Organization (WEO) defines post-colonoscopy colorectal cancers (PCCRCs) as CRC diagnosed 6 months after a colonoscopy that did not detect cancer. PCCRC is poorly understood as there is uncertainty about how often these cancers occur, their likely etiologies, the risk factors for these cancers, and whether they are more lethal than detected CRCs. To address these uncertainties, the WEO published a consensus statement to provide comprehensive guidance for the investigation of PCCRC cases. Their recommendations include a standardized definition for PCCRC, a defined method for calculating PCCRC rates, and standardized methods for performing qualitative reviews of cases to determine their likely etiology. The primary goal of the proposed study is to use recently published WEO methods to determine PCCRC rates, the likely etiologies for these cancers, their risk factors, and prognoses for PCCRC in the large integrated healthcare setting of Kaiser Permanente Northern California (KPNC).
Investigator: Lee, Jeffrey
Funder: Northern California Community Benefit Programs
Treatment Patterns and Clinical Outcomes in Patients with HR+/HER2- and HR+/HER2+ Metastatic Breast Cancer in an Integrated Health Care System
This is an observational, retrospective cohort study of patients diagnosed with HR+/HER2 – and HR+/HER2+ metastatic breast cancer (mBC) who initiated first-line systemic therapy in the metastatic setting. Study aims are: 1) Among HR+/HER2- mBC patients diagnosed from 2015-2020, describe demographic and clinical characteristics, treatment characteristics, and real-world progression-free survival. 2) Among HR+/HER2+ mBC patients diagnosed from 2012-2020, describe demographic and clinical characteristics, treatment characteristics, and progression-free survival and overall survival. 3) Identify demographic and clinical factors associated with first- and second-line treatment receipt (HR+/HER2-), treatment selection (HR+/HER2+), and their clinical outcomes.
Investigator: Kwan, Marilyn
Funder: Pfizer Inc.
NRG Oncology NCORP Research Base – NRG-CC005 FORTE (supplement)
In the initial phase of this study, we will manually review patients for eligibility for initial contact; complete a patient identification and tracking database; and develop and submit supplemental electronic IRB/email consent documents.
Investigator: Corley, Douglas
Funder: National Cancer Institute
Characterizing Colon Cancer Chemotoxicity Risk based on Epigenetic Age and Modification by Resistance Training Intervention
This study will investigate whether epigenetic aging — a molecular marker of biological age — at the start of chemotherapy is associated with chemotoxicity in patients receiving treatment for colon cancer. We will also look at whether chemotherapy treatment is associated with changes in epigenetic age, and the impact that resistance training during chemotherapy treatment has on these associations.
Investigator: Caan, Bette
Funder: National Cancer Institute
Influence of Comorbidities and Inflammatory Biomarkers in Disparities in Ovarian Cancer Treatment, Treatment Response, and Survival
This project examines racial and ethnic disparities in ovarian cancer patients diagnosed and treated in KPNC from 2000 to 2023. It is an ancillary study to an NCI-funded research project (R01 CA243188) led by MPIs Kushi, Doherty (University of Utah), Bandera (Rutgers University), and Gomez (UCSF). This is the largest multiethnic cohort of ovarian cancer survival to date to examine clinical and medical care; neighborhood and geospatial factors; reclassification of subtypes with updated information; and, in a subset of cases, tumor characteristics. This ancillary study extends this project with collection of pre-diagnostic information to explore the role of comorbid conditions. It also supports additional tumor assays examining inflammation markers in contributing to disparities in ovarian cancer outcomes.
Investigator: Kushi, Lawrence
Funder: The V Foundation for Cancer Research
Multi-panel Gene Mutation Testing and Targeted Therapy -STRATA Program
Identify KPNC patients with metastatic/incurable cancer for testing of tumors by next generation sequencing (NGS). NGS screening protocol is aligned to a portfolio of pharma-sponsored therapeutic protocols open now or theoretically open in the future, in addition to treatment off study or on NCI or non-STRATA trials.
Investigator: Habel, Laurel
Funder: The Permanente Medical Group
NCI Community Oncology Research Program (NCORP) – KP Community Site
The overarching goal of the KP NCORP Community Site is to bring the benefits of medical advances to our racially and ethnically diverse membership and to the community at large by increasing clinical trial access/accrual and by conducting cancer care delivery research (CCDR).
Investigator: Habel, Laurel
Funder: National Cancer Institute
Genomic and Transcriptomic Analysis of Mammographic Density
This study will combine functional data from gene expression and co-expression networks with GWAS data to elucidate the genetic determinants of mammographic density, an important risk factor for breast cancer.
Investigator: Habel, Laurel
Funder: National Cancer Institute
Improved Selection of BRCA-negative High-Risk Women for Breast MRI Screening through Validation of IBIS Risk Model Variants
The goal of this project is to identify the optimal IBIS model that maximizes screening benefits and minimizes harms. We hypothesize that the “full” model (with all breast cancer risk factors) has better calibration/discrimination compared to a reduced model that includes age and family history only. We also hypothesize that that “full” model will improve cancer yield without affecting MRI referrals.
Investigator: Habel, Laurel
Funder: TPMG Delivery Science Projects Program
Developing a TPMG Pathway for Selective Oncotype DX Testing in Early Breast Cancer
The goal of this project is to determine whether Ki-67 testing, using newer methods, could be used as a replacement for Oncotype DX testing in selected patients with HR+/HER2- breast cancer.
Investigator: Habel, Laurel
Funder: TPMG Delivery Science Projects Program
Radiomic and genomic predictors of breast cancer risk
Improving breast cancer risk prediction models could enable more personalized screening. This would enhance the benefits of screening while limiting the harms. This study will evaluate the performance of multi-feature image risk score models in a large population-based cohort; determine whether image-based scores predict breast cancer risk independently of clinical and genetic predictors; and ransfer the best image-based algorithm from 2D to 3D images.
Investigator: Habel, Laurel
Funder: National Cancer Institute
Leveraging Diversity in Cancer Epidemiology Cohorts and Novel Methods to Improve Polygenic Risk Scores
Inadequate representation of diverse racial/ethnic populations in genetic studies is hindering the translational potential of polygenic risk scores (PRS) in cancer risk prediction. To address this shortcoming, we aim to construct and evaluate PRS for cancer and estimate the absolute risk of cancer explained by PRS and non-genetic factors across multiethnic populations.
Investigator: Sakoda, Lori
Funder: National Cancer Institute
Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 in a Community Oncology Setting
This project will establish a prospective cohort of white and Black cancer patients treated with immune checkpoint inhibitors, leveraging the NCI Community Oncology Research Program network infrastructure, to investigate racial differences in immune-related adverse events and their predictors, treatment delay and discontinuation, and short- and long-term patient outcomes.
Investigator: Sakoda, Lori
Funder: National Cancer Institute
Long-term effectiveness of BPH/LUTS pharmacological therapies and using machine learning based predictive analytics to tailor treatment.
This career development award project will compare the effectiveness of pharmacological therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia in preventing long-term disease progression; and develop and validate predictive models using demographic, clinical, and laboratory data available at the time of diagnosis to identify patients at increased risk of long-term disease progression.
Investigator: Langston, Marvin
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Comparison of Risk factors, Clinical Characteristics, Screening performance, and Survival of Microsatellite Stable vs. Unstable Colorectal Cancers in a Large U.S. Population
Investigator: Li, Dan
Funder: Northern California Community Benefit Programs
Optimization of Diagnosis of Serrated Polyps of the Colorectum among KPNC Gastroenterologists and Pathologists
Investigator: Li, Dan
Funder: TPMG Delivery Science Projects Program
Evaluating Acceptance and Screening Yield for Early Colorectal Cancer Screening: (EASY Early CRC)
Three national guideline groups now recommend that all adults start colorectal cancer (CRC) screening at age 45. Before 2018, some guideline groups only recommended African Americans begin CRC screening at age 45. There is currently no empirical evidence of the value of screening before age 50. The only evidence comes from modeling studies and observational data collected in cancer registries, such as SEER. This project will evaluate the acceptance, uptake, and yield of mailed FIT screening among KP members in Northern California, Southern California, Washington, and Colorado. The findings will help National Guideline Directors make a recommendation to the Permanente Medical Groups and the Kaiser Foundation Health Plan about starting CRC screening at age 45.
Investigator: Levin, Theodore
Funder: Garfield Memorial Fund
De-Implementation of Outdated Colonoscopy Surveillance Interval Recommendations among Patients with Low-Risk Adenomas (DESIRE)
Recent guidelines have extended surveillance intervals for patients with low-risk adenomas from 5 years to 10. However, it remains unclear how to implement this change. In a pragmatic randomized 2-arm study of 1,000 patients with a history of low-risk adenomas and a standing 5-year surveillance recommendation, we will compare the effectiveness of secure messaging versus mailed outreach for adopting the new 10-year surveillance interval recommendation, continuing with the standing 5-year recommendation, or requesting a provider encounter (e.g., clinic or virtual visit) for shared decision making.
Investigator: Lee, Jeffrey
Funder: TPMG Delivery Science Projects Program
mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
This randomized controlled trial of an mHealth mindfulness intervention designed for Black and Latinx pregnant women at risk of developing postpartum depression will compare outcomes (depression, stress, sleep) of participants in the intervention with those in the control arm.
Investigator: Kubo, Ai; Avalos, Lyndsay
Funder: National Institute of Mental Health
Standardized ultrasound-based risk stratification for detection of ovarian cancer
This project, initiated in 2014, led to the development and large-scale implementation of a system for risk stratifying ovarian abnormalities seen on ultrasound to ensure that similar abnormalities are described in a similar way by radiologists. The system also allows clinical management to be consistent from patient to patient and aligned with actual ovarian cancer risk. A 2016 study showed the reporting categories defined by the system correlate with distinct levels of ovarian cancer risk. We are currently investigating the risks associated with specific ultrasound characteristics in a low-risk community-based population and how to improve the system to ensure prompt diagnosis of ovarian cancer while avoiding unnecessary surgery for women with benign ovarian cysts.
Investigator: Suh-Burgmann, Betty
Funder: The Permanente Medical Group
Implementation of large-scale HPV self-testing for cervical cancer screening
The goal of this project is to determine the best strategy for integrating a home-testing option for cervical cancer screening. The most sensitive screening test for cervical cancer and precancer is a PCR-based test for human papilloma virus (HPV), which was adopted in June 2020 as the primary screening method for women aged 25-64. Several large clinical trials have demonstrated the samples self-collected by patients for HPV testing are as accurate as samples collected by clinicians. The project aims to assess the acceptability and overall effectiveness of HPV self-testing using a prospective pragmatic cluster-randomized design. The study results will inform which patients are most likely to benefit from a home-testing strategy and factors that influence uptake and completion of screening.
Investigator: Suh-Burgmann, Betty
Funder: The Permanente Medical Group
Multi-Ancestry Mapping of Pancreatic Cancer Susceptibility Loci
This multiple institution effort will assemble the largest set of pancreatic cases and controls to examine in detail the genetic influences on the risk and progression of pancreatic cancer and perform exome sequencing of minorities with pancreatic cancer.
Investigator: Van Den Eeden, Stephen
Funder: National Cancer Institute
Energy Balance, mTOR Pathway Signaling, and Breast Cancer Prognosis: The Pathways Study
This application will use the Pathways Study resource to investigate genetic and non-genetic factors in the interplay of energy balance, mTOR signaling, and breast cancer prognosis. mTOR expression will be determined in tumor tissue from tissue microarrays that are being created in the Pathways Study, and its role in breast cancer outcomes will be examined.
Investigator: Kwan, Marilyn
Funder: National Cancer Institute
Racial/Ethnic Disparities in Ovarian Cancer Treatment and Survival: An Integrative Approach
We reported previously that African American and Hispanic women have worse survival after ovarian cancer diagnosis than white women, and Asian women have similar survival. We will investigate reasons for these disparities, focusing on tumor subtypes, health care, and neighborhood-level factors.
Investigator: Kushi, Lawrence
Funder: National Cancer Institute
PREEMPT CRC: Prevention of Colorectal Cancer Through Multiomics Blood Testing
The primary objectives of this study are to determine the sensitivity and specificity of Freenome’s test for colorectal adenocarcinoma, using screening CS with histopathology as the reference method.
Investigator: Levin, Theodore
Funder: Freenome Holdings, Inc
Non-alcoholic Fatty Liver Disease Prevalence and Associated Mortality (NAFLD PAM)
This study will investigate the incremental yield of using radiology imaging report information to diagnose non-alcoholic fatty liver disease (NAFLD) compared to International Classification of Disease, Ninth/Tenth Revision, Clinical Modification diagnoses alone in adult Kaiser Permanente Northern California members between 2009-2018, and whether the use of the Dallas Steatosis Index identifies additional individuals at high risk for NAFLD. The study will also and look at whether patients with NAFLD are at increased risk for all-cause mortality compared to the general population.
Investigator: Levin, Theodore
Funder: Northern California Community Benefit Programs
Prediction of Postoperative Urinary Retention in a Large Integrated Health System
Postoperative urinary retention (POUR) is the inability to void despite a full bladder following a surgical procedure. POUR can result in painful catherization, increased patient distress, increased postoperative hospital stay, urinary tract infections, detrusor muscle dysfunction, and cardiac arrhythmias. This research will lead to the development of a preoperative tool that can risk stratify patients based on risk factors for POUR and help providers develop a care plan to reduce patients’ risk.
Investigator: Langston, Marvin
Funder: Northern California Community Benefit Programs
COVID-19 Pandemic: Impact on Colorectal Cancer Screening and Adenoma Surveillance Outcomes (PICASO)
The goal of this project is to evaluate the impact of the COVID pandemic on colorectal cancer screening and surveillance activities, and the impact on outcomes such as colorectal cancer incidence and stage.
Investigator: Levin, Theodore
Funder: Garfield Memorial Fund
An Electronic Health Record-Based Tool to Identify Newly Diagnosed Breast Cancer Patients at Risk of Low Social Support
Goals of the project are to: 1) Identify terms from content in the EHR, based on theory and prior literature, and informed by clinical stakeholders in BC care, that measure structural and/or functional social support, have been associated with BC treatment and outcomes, and could be extracted through code or natural language processing (NLP); 2) Develop an EHR-based social support measure, EHR-SUPPORT, using data from structured, semi-structured, and unstructured (through NLP) sources that help identify patients at risk of low social support, overall and by race/ethnicity, and validate the measure against published social support measures; and 3) Evaluate associations of EHR-SUPPORT and its component variables with BC treatment outcomes (surgery delays, chemotherapy delays, nonadherence to hormonal therapy) and BC-specific and total mortality, overall and by race/ethnicity. In an exploratory aim, we propose to: Explore, with clinician stakeholders, workflow and information technology requirements to implementing EHR-SUPPORT.
Investigator: Kroenke, Candyce
Funder: National Cancer Institute
Informatics approaches to assessing patient frailty in surgical care
Patient frailty increases the risk for surgical complications, which are common, costly, and deadly, especially for older Americans. To improve surgical care for older adults, we will investigate whether electronic measures of frailty can help reduce complications by identifying which patients are likely to be readmitted to the hospital or die soon after surgery.
Investigator: Feliciano, Elizabeth
Funder: National Institute on Aging
Understanding Racial/Ethnic Disparities in Lung Cancer Screening Utilization
This study proposes to understand patterns and multilevel determinants of racial/ethnic disparities in Lung Cancer Screening utilization from 2017 onward at KPNC.
Investigator: Sakoda, Lori
Funder: Northern California Community Benefit Programs
The Colonic Microbiome Preceding Parkinson’s Disease: A Pilot Study
Gut changes, including evidence of alpha synuclein and the microbiome, appear to differ between people with and without Parkinson’s disease. This pilot study will use colonic biospecimens from deceased patients with Parkinson’s disease and control patients to determine if we can characterize the microbiome with good resolution and demonstrate at least one signal of microbiome differences between the two groups. Early studies have been positive. The findings will be used to support an NIH R01 application to fully elucidate the temporality of microbiome changes in prodromal Parkinson’s disease.
Investigator: Van Den Eeden, Stephen
Funder: University of California, San Francisco, Project Grant
Bipolar Disease and Parkinson’s Disease
This study, along with a parallel effort at the University of California, San Francisco, will focus on the relationship between bipolar disease and Parkinson’s disease.
Investigator: Van Den Eeden, Stephen
Funder: Michael J. Fox Foundation
Breast White Adipose Tissue Inflammation and Breast Cancer Outcomes
We will assess the incidence and severity of breast white adipose tissue (B-WAT) inflammation in mastectomy specimens from approximately 1,900 Pathways Study participants to examine associations of various factors with B-WAT inflammation incidence and severity at the time of breast cancer surgery, and to examine whether B-WAT inflammation impacts breast cancer recurrence, second primary breast cancer, and breast cancer progression-free survival. We will also investigate the associations of inflammatory blood biomarkers, body composition, and lifestyle factors such as diet and physical activity with B-WAT inflammation and severity. This collaborative project includes investigators at the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Roswell Park Comprehensive Cancer Center, and Weill Cornell Medical College, where Dr. Andrew Dannenberg, who co-leads this project, is located.
Investigator: Kushi, Lawrence
Funder: National Cancer Institute
Body Composition and Breast Cancer Survival: Immune and Metabolic Biomarkers in Breast Tumors
We previously found that one third of nonmetastatic breast cancer patients had sarcopenia (age-related loss of muscle tissue) at the time of their diagnosis and that having sarcopenia and obesity was associated with an 89% increased risk of death. This study will use 1,400 archived clinical tumor tissues from stage II-III breast cancer patients for whom we have data on body composition, metabolic syndrome, weight history, cancer therapy, and long-term follow-up for breast cancer outcomes. We will classify breast cancer molecular subtypes, measure gene expression levels in immune and metabolic pathways potentially influenced by body composition and the metabolic syndrome, and examine whether alterations in the breast cancer tumor microenvironment mediate the association of body composition and breast cancer survival.
Investigator: Feliciano, Elizabeth
Funder: National Cancer Institute
Recurrence, Treatment, and Complication Patterns of Intermediate Risk Non-muscle Invasive Bladder Cancer
This study will comprehensively assess the clinical course of intermediate risk non-muscle invasive bladder cancer (NMIBC) in 291 patients diagnosed at Kaiser Permanente Northern California who are enrolled in the Be-Well Study. Intermediate risk NMIBC is an understudied form of one of the most common urologic cancers in the U.S. We will examine recurrence and progression patterns of intermediate risk NMIBC; determine complications associated with its diagnosis and treatment; and characterize healthcare utilization related to its surveillance.
Investigator: Kwan, Marilyn
Funder: UroGen Pharma, Inc.
PREDICT PCCC: PREDICTing Post Colonoscopy Colorectal Cancer
We are using post-polypectomy surveillance, an increasingly common indication for colonoscopy in clinical practice at TPMG and across the United States, as a model for how we might risk-stratify patients for care. Patients and physicians desire more precise estimates of risk for cancer after the removal of benign colorectal polyps to guide when they should have repeat surveillance with colonoscopy. We aim to evaluate a traditional risk prediction model compared with a deep learning model to improve the accuracy of risk scoring for post-colonoscopy colorectal cancer and guide personalized care
Investigator: Levin, Theodore
Funder: The Permanente Medical Group
NRG Oncology NCORP Research Base
This is a non-inferiority trial design comparing colorectal cancer incidence in trial participants with 1-2 non-advanced adenomas randomized to recommendation for a 5- and 10-year surveillance colonoscopy exam vs. a 10-year surveillance colonoscopy exam.
Investigator: Corley, Douglas
Funder: National Cancer Institute
Kaiser Permanente Interregional Cancer Statistics Project
A Kaiser Permanente interregional cancer statistics report will be developed to include incidence and 5-year relative survival rates for breast, colorectal, and lung cancer. The development of new mortality measures will be explored, along with improved routine capture and reporting of these measures. Work will include a landscape review of current procedures and methods used by regional cancer committees to generate region-specific reports; generation of estimates of cancer-specific mortality and all-cause mortality; and assessment of interregional available death and cause of death data. Finally, sustainable reporting processes will be created to enhance the organization’s ability to produce this report on an annual basis.
Investigator: Kushi, Lawrence
Funder: Center for Effectiveness and Safety Research
D3-creatine dilution to assess skeletal muscle mass in colon cancer patients
Among colon cancer patients participating in a resistance training intervention during chemotherapy, this study will examine whether a new method to evaluate skeletal muscle mass (d3-creatine dilution) is associated with the key cancer outcomes of strength and physical function, chemotherapy toxicity, inflammation, cardiometabolic risk factors and markers of tumor recurrence.
Investigator: Feliciano, Elizabeth
Funder: National Cancer Institute
Pediatric obstructive sleep apnea: predictive modeling to streamline care
To prioritize pediatric attended polysomnography and treatment for children most in need while reducing the unnecessary use of overnight sleep studies, we propose to build and rigorously evaluate a clinical risk prediction model. We will combine data from pediatric sleep questionnaires with other risk factors derived from the electronic medical record to predict obstructive sleep apnea severity among pediatric sleep patients and evaluate our model’s performance in an independent sample.
Investigator: Feliciano, Elizabeth
Funder: The Permanente Medical Group
Healthful dietary patterns, intermediate biomarkers and long-term breast cancer prognosis
To strengthen the dietary guidelines for breast cancer survivors, we examine whether at-diagnosis concordance with healthful dietary patterns is associated with recurrence or breast cancer death, or with prognostic biomarkers (i.e., body composition, inflammation or metabolic syndrome). Secondarily, we will examine whether improving diet quality (or maintaining high diet quality) after diagnosis reduces risk of recurrence or breast cancer death.
Investigator: Feliciano, Elizabeth
Funder: American Institute for Cancer Research
Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer (CPDPC) and the National Community Oncology Research Program (NCORP)
The New-Onset Diabetes Cohort Study is designed to help develop and test early detection tests and processes. Kaiser Permanente Northern California is collaborating in this multi-site study to identify, recruit, and follow up with members who have recently been identified as having a dysglycemia or new-onset diabetes. Participants will be asked to provide questionnaire data and biospecimens over a three-year period. Patients who complete a baseline visit will receive a $50 gift card and an additional card for each follow-up visit completed and verified.
Investigator: Van Den Eeden, Stephen
Funder: National Cancer Institute
Sex and Race/Ethnicity-specific Multilevel Factors Influencing Pubertal Trajectories: A Population-based Study
The goal of this project is to describe the normative distributions of pubertal development among boys and girls by race/ethnicity and to investigate early-life risk factors affecting pubertal onset and tempo (velocity of transition between onset and maturation). We will also examine contextual factors such as the social and built environment as potential risk factors.
Investigator: Kubo, Ai
Funder: National Institute of Child Health and Human Development
PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota (CP101) in Subjects with Recurrence of Clostridium difficile Infection
This study evaluates the safety and efficacy in reducing recurrence of Clostridium difficile infection in adults who had a recurrence within 8 weeks of receiving CP101 or placebo in PRISM3. Subjects who are experiencing recurrent Clostridium difficile infection will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in the extension study and administered CP101.
Investigator: Levin, Theodore
Funder: Finch Research and Development, LLC
Body Composition and the Obesity Paradox in Clear-Cell Renal Cell Carcinoma
Aim 1: Determine associations among body mass index (BMI), body composition variables, and tumor subtype. The amount and quality of muscle, visceral adipose tissue, and subcutaneous adipose tissue will be derived from existing pre-surgical CT scans; and ccA/ccB subtypes will be derived from archived tumor specimens using NanoString.
Aim 2. Identify body composition variables independently associated with ccRCC prognosis after accounting for tumor subtype. Multivariable models adjusting for demographics, BMI, comorbidities, and known prognostic factors will estimate how body composition variables are associated with disease progression, cancer-specific, and overall survival and whether these associations are modified or mediated by tumor subtype.
Aim 3. Identify novel pathways through which body composition may affect prognosis.
Investigator: Caan, Bette
Funder: National Cancer Institute
Cancer and Body Composition Webinar Series
This monthly webinar series, attended by approximately 200 people from diverse disciplines, is ongoing and focuses on topics relevant to body composition and cancer. The Division of Research will host 10 webinar speakers who are prominent in the field; archive recordings; and write a paper summarizing advances in the field.
Investigator: Caan, Bette
Funder: National Cancer Institute
Geospatial, Multilevel, and Contextual Approaches in Cancer Control and Population Sciences
This funding expands on neighborhood resources developed under the U01 grant (geocoded residential histories, linkage to census and area databases, virtual neighborhood audits). Aim 1: Develop methods to use remote sensing data and machine learning techniques to characterize neighborhood attributes (e.g., green space, proximity to blue space, night-time light) and enhance the neighborhood infrastructure of the Pathways Study cohort. Aim 2: Demonstrate their applicability by examining the impact of social and built environment attributes on allostatic load among the Pathways cohort of breast cancer survivors. This work provides an opportunity to apply a comprehensive suite of neighborhood attributes to better understand multilevel factors and outcomes in breast cancer survivors.
Investigator: Kushi, Lawrence
Funder: National Cancer Institute
A Multicenter Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota (CP101) in Subjects with Recurrence of Clostridium Difficile Infection
The objectives of this Phase 2 study are to evaluate the safety and tolerability of CP101 treatment compared to placebo in adults with previously treated, recurrent Clostridium difficile infection, and to evaluate the efficacy of CP101 treatment relative to placebo in adults with previously treated, recurrent Clostridium difficile infection.
Investigator: Levin, Theodore
Funder: Finch Research and Development, LLC
Social Networks and Disparities in Health Behaviors and Breast Cancer Outcomes in Immigrant Women
The goals of this study are to evaluate associations between: 1) immigrant status and social networks at the neighborhood level and at the individual level, overall and by race/ethnicity, further evaluating associations among Asian/Pacific Islander and Hispanic, relative to non-Hispanic white women; 2) immigrant status and multilevel social network characteristics with behavioral factors known to influence breast cancer survival, overall and by race/ethnicity; and 3) immigrant status, multilevel social network characteristics, and breast cancer outcomes including recurrence, breast cancer-specific mortality, and total mortality, overall and by race/ethnicity, evaluating the degree to which social network characteristics and behavioral risk factors mediate associations.
Investigator: Kroenke, Candyce
Funder: National Cancer Institute
Comprehensive Translational Science Analytics Tools for the Global Health Agenda
This project builds on a previous Community Benefit grant award to examine changes in cervical and colorectal cancer screening as a result of the implementation of the Patient Protection and Affordable Care Act. It will examine impacts on colorectal cancer incidence and mortality. This will be supported through a collaboration with Dr. Donna Spiegelman of Yale University, through an NIH Pioneer Award to Dr. Spiegelman, DP1 ES025459
Investigator: Kushi, Lawrence
Funder: National Institute of Environmental Health Sciences
Circulating Biomarker Consortium for Pancreatic Early Detection
This is a retrospective case-control study to examine the timing and magnitude of loss of muscle and adiposity prior to diagnosis of pancreatic cancer.
Investigator: Caan, Bette
Funder: Dana Farber Cancer Institute
System-Level Capture of Family History Data to Assess Risk of Cancer and Provide Longitudinal Care Coordination
Genetic risk and family history, which includes personal medical history, increasingly influence medical care, but optimal methods for capturing the hereditary risk of disease and the outcomes of such assessments are unknown. Using inherited cancer as a model, this study will: 1) Test scalable interventions for integrating family and genetic risk data into the care of large populations; 2) Evaluate significant patient-centered and medical-outcomes resulting from systems-level family history assessment; and 3) Determine the resources needed for such interventions.
Investigator: Corley, Douglas
Funder: Patient-Centered Outcomes Research Institute
Germline and Tumor Genomic Analyses of Breast Cancer in Latinas
This project expands a consortium of studies examining germline genetic mutations in breast cancer risk in Latinas. It builds on a study that will include approximately 550 Latina women with breast cancer in the Pathways Study; genetic data from Latina women without breast cancer will be contributed from Kaiser Permanente Northern California’s Research Program on Genes, Environment and Health. Led by Susan Neuhausen, PhD, of City of Hope, and Elad Ziv, MD, of UC San Francisco, this project further incorporates Latina cases and controls from studies led by Dr. Neuhausen. While this project includes investigation of tumor DNA, Pathways Study and Kaiser Permanente Northern California participants will not be included in that aspect.
Investigator: Kushi, Lawrence
Funder: National Cancer Institute
Optimizing Long-Term Post-Polypectomy Surveillance for Colorectal Cancer Prevention Using a Prediction Rule Developed from a Large, Community-Based Cohort
Screening has been shown to reduce colorectal cancer incidence and mortality. However, screening has resulted in a growing cohort of patients with adenomatous polyps (adenomas), and little is known about effectively managing their post-polypectomy surveillance. With limited data available in the literature to determine the appropriate timing and frequency of follow-up colonoscopy for patients after adenoma removal, recommendations for post-polypectomy surveillance from our national guidelines have been imprecise at best. To fill this knowledge gap, this project aims to: 1) determine the long- term colorectal cancer risk in patients after colonoscopic polypectomy in a very large “real world” community-based population; 2) identify patient-, polyp-, and exam-related risk factors associated with incident colorectal cancer in these patients; and 3) develop a risk prediction model that will identify post- polypectomy patients at high and low risk for developing subsequent colorectal cancer.
Investigator: Lee, Jeffrey
Funder: National Cancer Institute
Adolescent and Young Adult Female Cancer Survivors – Cancer Experience Survey
This study aims to: 1) assess reproductive intentions and receipt of fertility counseling or preservation in relation to post-diagnosis birth outcomes among adolescent and young adult cancer survivors in North Carolina and the Kaiser Permanente Northern California and Kaiser Permanente Southern California health systems; 2) examine infertility, pregnancy loss history, and use of infertility services among adolescent and young adult cancer survivors within those health systems compared to the U.S. general population; and 3) examine the frequency of self-reported cancer recurrence among adolescent and young adult female cancer survivors in North Carolina and in those health systems, and examine the impact of cancer recurrence on post-diagnosis birth rates. Current recommendations for when to attempt pregnancy after cancer diagnosis (typically two to five years) are often based on identified periods of highest cancer recurrence risk, rather than optimal timing for achieving pregnancy, but recurrence information is rarely available.
Investigator: Kushi, Lawrence
Funder: University of North Carolina
Validation and Extension of the Michigan Barrett’s Esophagus pREdiction Tool (M-BERET)
This project will validate whether a clinical tool can predict the presence of Barrett’s esophagus and the development of esophageal adenocarcinoma.
Investigator: Corley, Douglas
Funder: U.S. Department of Veterans Affairs
Gene Dependent Cancer Risk and Optimal Cancer Prevention Strategies in Lynch Syndrome
As part of a “K” training award from the National Institutes of Health, and within the overall colorectal cancer research program at Kaiser Permanente Northern California, this project will support additional analyses regarding the identification of persons at high hereditary risk for colorectal cancer (e.g., Lynch syndrome) and their use of preventive and treatment modalities.
Investigator: Corley, Douglas
Funder: National Cancer Institute
Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCEED)
The goal of the PROCEED study is to determine the early markers or predictors of progression among individuals with pancreatitis. Participants will undergo focused study-related procedures and questionnaires at enrollment and regularly during follow-up as outlined in the protocol. The type of procedures to be completed will depend on their pancreatitis severity.
Investigator: Van Den Eeden, Stephen
Funder: National Institutes of Health
Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer: Coordinating and Data Management Center
The NOD (New-Onset Diabetes) Cohort Study is part of a multisite effort to create a cohort with strictly defined new-onset diabetes. Kaiser Permanente Northern California is also receiving funding from the National Cancer Institute Community Oncology Research Program (NCORP). The full study is designed to recruit 10,000 participants with new-onset diabetes from across the nation and follow them closely with questionnaire data for at least a 3-year period. Biospecimens will also be obtained at regular intervals. The primary goals of the study are to: 1) estimate the risk of pancreatic and other cancers within a 3-year period after new-onset diabetes; 2) create a biospecimen resource for the development of biomarkers for pancreatic cancer; and 3) serve as a validation set for externally developed biomarkers.
Investigator: Van Den Eeden, Stephen
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Beyond Body Mass Index: Bringing Body Composition into Oncology Practice
This project consists of development of electronic tools to rapidly assess body composition in colorectal cancer and breast cancer patients and present this information to clinicians. It leverages Kaiser Permanente Northern California’s electronic medical records and repository of CT images, including 6,000 images from colorectal cancer and breast cancer patients that were previously manually analyzed for body composition. This project has three major aims: validate software to automatically assess body composition from clinically-acquired imaging (Aim 1); improve the predictive performance of established colorectal cancer risk prediction models through the addition of body composition variables (Aim 2); and develop a prototype of an electronic decision support tool that presents personalized patient risk information to clinicians in an understandable and actionable format (Aim 3).
Investigator: Feliciano, Elizabeth
Funder: National Cancer Institute
Development of the Kaiser Permanente Prostate Cancer Risk Calculator
Much of the controversy surrounding prostate cancer screening is due to the poor predictive value of PSA blood tests and the risks attendant to over-diagnosis. This project aims to develop a risk calculator that uses clinical variables to determine the risk of having prostate cancer, the risk of having high-grade prostate cancer (defined as Gleason scores of 7 to 10), or the risk of having an indolent prostate cancer. A retrospective cohort study of 2000 men who have undergone biopsy at Kaiser Permanente Northern California will be used to generate a predictive model, which will then be validated with data from 1000 additional patients. A detailed comparison with age-specific PSA reference ranges and an existing risk calculator from the Prostate Cancer Prevention Trial will be performed to determine the new model’s clinical utility. The Kaiser Permanente Prostate Cancer Risk Calculator will stratify patients into cancer-risk categories that will better enable both patients and physicians to more accurately determine the need for biopsy.
Investigator: Presti, Joseph
Funder: The Permanente Medical Group
End-of-Life Care for Adolescents and Young Adults with Cancer: An Evaluation of Care and Development of Patient-Centered Quality Measures
This project examines aspects of end-of-life care for people diagnosed with adolescent and young adult cancers (ages 15 to 39 years). Current measures of end-of-life care quality were designed for older adults; a coherent set of measures to characterize high-quality end-of-life care for adolescent and young adult cancer patients does not exist. This study seeks to answer the questions: What is the quality of end-of-life care for adolescents and young adults with cancer, and what is a patient-centered definition of high-quality end-of-life care for adolescents and young adults facing terminal illness? The aims of this project are to examine the quality of end-of-life care in adolescent and young adult cancer patients, identify sources of variation in end-of-life care, and develop a set of indicators of end-of-life care quality suitable for adolescent and young adult cancers. Data from about 1,800 patients diagnosed from 2000 to 2015 with adolescent and young adult cancers in Kaiser Permanente Northern California and Kaiser Permanente Southern California will be included in data-only aspects, with in-depth interviews of patients, family members, and providers from these Kaiser Permanente regions and the Dana-Farber Cancer Institute to better identify factors that may improve end-of-life care quality. This project is led by Dr. Jennifer Mack at the Dana Farber Cancer Institute.
Investigator: Kushi, Lawrence
Funder: National Cancer Institute
Obesity, Chemotherapy Dosing, and Breast Cancer Outcomes
Body size is associated with survival in women with breast cancer in complicated ways. Chemotherapy to treat breast cancer is typically dosed based on body size, often as a function of body surface area. Previously, there was concern that obese patients may receive doses of chemotherapy that may be too toxic given their higher body surface area, resulting in dose capping. This has resulted in the suggestion that obese women were receiving less-than-optimal doses for cancer treatment. Indeed, in 2012, the American Society of Clinical Oncology recommended that doses of chemotherapy not be capped. This project, enabled by availability of detailed infusion data, examines the impact of body size on chemotherapy dosing and subsequent outcomes. The project builds upon pilot work conducted in the Pathways Study cohort of 4,505 women with breast cancer, expands to other women with electronic data only, and includes over 4,000 women with breast cancer at Kaiser Permanente Washington. This project is led by Dr. Elizabeth Kantor at Memorial Sloan Kettering Cancer Center.
Investigator: Kushi, Lawrence
Funder: National Cancer Institute
Optimizing Colorectal Cancer Screening PREcision and Outcomes in CommunIty-baSEd Populations (PRECISE)
This study is part of the Population-Based Research Optimizing Screening through Personalized Regimens (PROSPR) program, which aims to enhance understanding of the implementation and effects of screening as practiced in multiple, heterogeneous health care environments in the United States. Within this program, proposed research projects must cover long-term observations of diverse cohorts of patients who are eligible for screening. In addition to observational research to evaluate factors that affect the quality of the screening process, projects must also develop and pilot-test interventions aimed at improving the screening process. This study of colorectal cancer screening precision and outcomes will build upon work completed and in progress from the first five years of PROSPR.
Investigator: Corley, Douglas
Funder: National Cancer Institute
Outreach for Colorectal Cancer Screening in African Americans Aged 45 to 49
This study aims to 1) evaluate uptake of fecal immunochemical testing among African Americans aged 45 to 49 who receive outreach for such testing by mail, 2) examine the yield of screening results, including advanced adenomas and colon cancers, and 3) describe adverse events of screening among this population and compare them to those seen in people aged 50 to 55.
Investigator: Levin, Theodore
Funder: The Permanente Medical Group
Air Pollutants and Cardiovascular Risk: Investigating Thresholds with Pooled Cohorts and Electronic Health Records
This study will pool data from a set of well-established cohorts in the United States, each with appropriate outcome, residential history, and individual-level covariate detail, to study low-threshold exposures to criteria air pollutants and cardiovascular disease risk. A secondary aim is to study one unusually well-characterized large-scale integrated health delivery system (Kaiser Permanente Northern California) with detailed electronic health records, as well as cohorts within the system, to examine the consistency between a cohort and electronic-health-record approach.
Investigator: Van Den Eeden, Stephen
Funder: National Institute of Environmental Health Sciences
Pilot Study of the Collection and Integration of Patient-Reported Outcomes in Those with Metastatic Pancreatic Cancer
This study seeks to 1) assess the feasibility and challenges associated with incorporating patient-reported outcomes into Kaiser Permanente HealthConnect, implement the collection of patient-reported-outcome measures among patients newly diagnosed with metastatic pancreatic cancer, 3) characterize patient-reported physical function and associated clinical status over time in these patients, and 4) determine the concordance and discordance of patient-reported physical function with clinician-reported physical function and performance status. The principal investigator is Piyush Srivastava, MD, of the hematology and oncology departments at Kaiser Permanente Diablo.
Investigator: Van Den Eeden, Stephen
Funder: The Permanente Medical Group
Assessing Adherence to Follow-Up Care After Low-Dose Computed Tomography Screening for Lung Cancer
With the recent implementation of lung cancer screening in community-based practice, little is currently known about utilization patterns and outcomes in patients following the initial low-dose computed tomography (CT) screening exam. The primary goals of this study are to 1) examine adherence to recommended follow-up based on initial low-dose CT screening exam results and 2) identify factors associated with adherence (versus non-adherence) to recommended follow-up.
Investigator: Sakoda, Lori
Funder: Northern California Community Benefit Programs
mHealth Mindfulness Intervention for Women with Perinatal Depression: A Feasibility Study
The primary goal of this project is to assess the feasibility of conducting a mobile-health mindfulness intervention (mHealth) study among pregnant and postpartum women with depressive symptoms. Perinatal depression has numerous adverse health consequences, including preterm delivery, negative maternal-infant interaction, and child behavior problems. We will recruit ~30 women who present symptoms of perinatal depression from the OBGYN clinics at Kaiser Permanente and use a single-arm intervention design to assess the feasibility of conducting a six-week mHealth mindfulness intervention. We will also obtain preliminary efficacy results consisting of patient-reported outcomes on depression, anxiety, perceived stress, health behaviors, mindfulness, and sleep.
Investigator: Kubo, Ai
Funder: Northern California Community Benefit Programs
Race Disparities in Social Networks, and Breast Cancer Treatment, Prognosis
The goal of this research is to determine, through the use of mixed qualitative and quantitative methods, how the social environment influences women’s breast cancer treatment, decisions about treatment, and subsequent survival, and how these relationships may help to explain racial disparities in breast cancer survival. This research may have implications for possible social interventions in breast cancer survivors.
Investigator: Kroenke, Candyce
Funder: American Cancer Society
Optimization of Diagnosis and Surveillance of Colonic Sessile Serrated Adenomas by Pathologists and Gastroenterologists at Kaiser Permanente Northern California
Investigator: Li, Dan
Funder: The Permanente Medical Group
Resistance Training to Reduce Chemotoxicity in Colon Cancer
The goal of this study is to test a randomized intervention of up to six months of home-based resistance training and protein supplementation versus a waitlist control. The intervention will begin during the first month of chemotherapy and continue through completion of treatment. The study will examine differences in chemotherapy outcomes, including reductions in dosing, treatment delays, and early discontinuation of treatment; differences in total combined number of moderate and severe grade 3 and 4 toxicities; and pre and post intervention differences in the pharmacokinetics of FOLFOX (colon cancer chemotherapy regimen), changes in body composition, functional status, and strength. If improving muscle mass through resistance training leads to a reduced risk of chemotoxicities, CT scans routinely performed for clinical diagnosis could be used to identify high-risk patients who will benefit from tailored exercise guidelines.
Investigator: Caan, Bette
Funder: National Cancer Institute
A Pilot Pragmatic Trial of mHealth Mindfulness Intervention to Improve Quality of Life Among Metastatic Cancer Patients and Their Caregivers
Screening for psychosocial distress is an accreditation requirement of the Commission on Cancer, underscoring the importance of addressing cancer patients’ psychosocial needs. Mindfulness-based training is one strategy that has been shown to help cancer patients reduce distress and improve quality of life. However, logistical requirements of standard in-person mindfulness classes make it impractical for cancer patients to receive benefit. To address this issue, we have conducted a few studies that demonstrated the feasibility, acceptability, and preliminary efficacy of non-face-to-face mindfulness approaches (e.g., CD, MP3 and mobile app). Building on these studies, this project will pilot test the feasibility of implementing a mobile/online-based mindfulness program for advanced cancer patients and their caregivers in a cluster randomized trial involving six oncology clinics.
Investigator: Kubo, Ai
Funder: The Permanente Medical Group
Clinical Pregnancy Outcomes in Adolescent and Young Adult Female Cancer Survivors
Post-diagnosis fertility is a critical issue for adolescent and young adult cancer survivors (diagnosed at age 15 to 39 years), with little information on the impact of cancer diagnosis and treatment on pregnancy outcomes. This study focuses on five leading cancer types among female adolescent and young adult cancer survivors: breast, melanoma, thyroid, and Hodgkins and non-Hodgkins lymphomas. We will analyze North Carolina state-wide cancer registry data linked to claims and offspring birth records from 2003 to 2012, as well as data from Kaiser Permanente Northern California (KPNC) and Kaiser Permanente Southern California (KPSC) for 2000 to 2016. Study aims include assessment of adverse pregnancy outcome risk among 7,200 female adult and young adult cancer survivors at KPNC and KPSC, with 1,300 births, matched five-to-one to 36,000 women without a prior cancer diagnosis on age and enrollment year. Adverse pregnancy outcome risk will also be assessed among 8,000 female adult and young adult cancer survivors in North Carolina, matched five-to-one on maternal age, state, and delivery year. Additionally, the impact of fertility preservation counseling and use on risk of adverse pregnancy and birth outcomes will be evaluated.
Investigator: Kushi, Lawrence
Funder: National Cancer Institute
Effectiveness of Screening for Colorectal Cancer in Average Risk Adults: Colonoscopy vs. Fecal Immunochemical Test (FIT)
This project will evaluate the effectiveness of screening fecal immunochemical testing (FIT) versus screening colonoscopy in reducing the risk of death from colorectal cancer in average risk men and women who receive their care in community settings. We will also develop new statistical methods to account for levels of adherence to recommended screening intervals when comparing tests.
Investigator: Corley, Douglas
Funder: National Cancer Institute
Predictors of CVD among Breast Cancer Survivors in an Integrated Health System
This study will comprehensively examine clinical and behavioral predictors of cardiovascular disease (CVD) outcomes among breast cancer survivors, and will maximize unique patient and data resources available at Kaiser Permanente Northern California (KPNC). We will compare CVD events in the Pathways Study, a cohort of female KPNC members age ≥21 years diagnosed with invasive breast cancer (n=4,453, R01CA105274) with CVD events in a new age, race/ethnicity, history of comorbidity, and length of KPNC membership matched cohort of healthy KPNC female members (n=22,265). Results from this study will have important implications for identifying breast cancer subgroups at high risk of CVD and identifying potential targets for intervention, such as medication adherence and control of CVD risk factors.
Investigator: Kwan, Marilyn
Funder: National Cancer Institute
Comprehensive Colorectal Cancer Risk Prediction to Inform Personalized Screening
The aims of this study are: 1) To build a comprehensive risk-prediction model for colorectal cancer and advanced adenoma in 45,000 colorectal tumors and 45,000 controls based on existing common and rare genome-wide genetic variants, demographic characteristics, and lifestyle and environmental risk factors. 2) To evaluate the risk-prediction models by calibrating and validating the models in the community-based RPGEH cohort and compare it with current screening guidelines and published risk prediction models. 3) To translate abstract risk prediction estimates into individually tailored recommendations that can be used in public health and clinical settings. We will use our developed absolute risk estimates to recommend age to start intervention and the type of screening modality. We will also incorporate a cost-benefit in the decision curve analysis to help clinical decision making.
Investigator: Corley, Douglas
Funder: National Cancer Institute
Susceptibility Genes for Erectile Dysfunction
This Multi-PI grant (H. Wessells, UW & S. Van Den Eeden KPNC) will 1) develop phenotyping algorithms, 2) examine genetic factors that affect risk, and 3) assess if these factors differentially affect subgroups (e.g., diabetic men, etc.). The study will use the eMerge Network and RPGEH populations.
Investigator: Van Den Eeden, Stephen
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Urban Forestry’s Return on Investment: Tying Residential Nature to Health Care Expenditure
This study will examine how urban greenspace is related to health costs. Numerous of studies have documented the connection between urban and community forests and human health: in greener places, people are healthier. However, many of these studies lack spatial resolution and/or important covariate data that precludes definitive assessments. We will link LiDAR and other satellite data to characterize urban forest/greenspace in high spatial detail and link to the individual level health endpoints and costs within a large and diverse integrated health delivery system. We will also examine how greenspace is related to these outcomes with consideration of socioeconomic status and comorbidity.
Investigator: Van Den Eeden, Stephen
Funder: U.S. Forest Service
Association between the Genomic Prostate Score and Metastatic Recurrence
The primary goal of the study is to confirm that the pre-specified Genomic Prostate Score (GPS) from biopsy tumor tissue predicts metastatic recurrence (MR) in patients diagnosed with localized prostate cancer and treated with radical prostatectomy. Prostate cancer-specific death (PCSD) will be evaluated as a secondary endpoint.
Investigator: Van Den Eeden, Stephen
UCSF-Kaiser Permanente Urological Epidemiology Research Career Development Program
This is a collaborative response to the request for a K12 training program in benign urological epidemiology. UCSF and Kaiser Permanente will jointly support two post-doctoral fellows.
Investigator: Van Den Eeden, Stephen
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Being Present: A Feasibility Study of Audio-Based Mindfulness Meditation Intervention for Metastatic Cancer Patients and Caregiver
Based on our previous pilot study of CD-based mindfulness intervention for cancer patients, we propose to develop a mobile application and pilot test its acceptability among cancer patients and their caregivers in order to reduce stress and to improve quality of life. We will hold a focus group to obtain participants feedback regarding the mobile-based intervention, and conduct an 8-week feasibility study using the application.
Investigator: Kubo, Ai
Funder: Kaiser Permanente Institutional Planned Giving
Chronic Pancreatitis, Diabetes and Pancreatic Cancer: A Prospective Approach
Kaiser Permanente is a founding site of the NIDDK/NCI Consortium to Study Chronic Pancreatitis, Diabetes and Pancreatic Cancer. The goal of consortium is to better understand relationships between chronic pancreatitis, diabetes and pancreatic cancer. As part of the study, we will prospectively follow a cohort of individuals at high risk of pancreatic cancer to assess risk and determine modifying characteristics.
Investigator: Van Den Eeden, Stephen
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Mobile App-Based Mindfulness Pilot Study for Cancer Patients and Caregivers
This pilot randomized trial will test the feasibility of a mobile-app based mindfulness intervention for cancer patients and their caregivers in order to reduce stress, and to improve quality of life and patient-provider communication.
Investigator: Kubo, Ai
Funder: American Cancer Society
Grant Development Work for Molecular Assay in Prostate Cancer
The goal of the study is to perform a retrospective study to evaluate biomarkers predictive of aggressive disease using Florescence In Situ Hybridization (FISH) among men with histologically confirmed, clinically localized disease (T1c- T2c) under Active Surveillance (AS).
Investigator: Van Den Eeden, Stephen
Funder: Abbott Laboratories
Infrastructure for Pathways, a Prospective Study of Breast Cancer Survivorship
This grant provides core infrastructure support for the Pathways Study (Kushi, PI), a prospective cohort study of breast cancer survivorship and prognosis. Since 2006, the study enrolled 4,505 women diagnosed with invasive breast cancer in KPNC. Activities (Ambrosone, Christine, Roswell Park Cancer Institute, Co-PI) include ongoing follow-up of participants, active and passive ascertainment of outcomes, collection of tumor specimens, linkage to KPNC electronic records, enhancement of area-level data from contextual databases through virtual neighborhood audits, provision of genotypic data from genome-wide assays, and establishment of a community and participant advisory board. These activities enhance the Pathways Study to make it an unparalleled, outstanding resource for studies of breast cancer prognosis.
Investigator: Kushi, Lawrence
Funder: National Cancer Institute
Kaiser Permanente PROSPR Cervical Cancer Prevention and Screening (CCaPS) Center
The purpose of this project is to expand PROSPR’s activities related to screening women for cervical cancer. PROSPR is the National Cancer Institute’s Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) consortium. This specific application will extend an existing collaboration between Kaiser Permanente’s Northern and Southern California regions to include data collection and analyses on cervical cancer with co-principal investigators Michael Silverberg (KPNC) and Chun Chao (KPSC).
Investigator: Corley, Douglas
Funder: National Cancer Institute
Novel Air Pollution Mapping and Health Disparities in Oakland, CA
The Environmental Defense Fund is collecting air pollution data for high resolution air quality mapping. The study region will include areas of East, West and downtown Oakland, as defined by the boundaries of the data collected by the Environmental Defense Fund. Air pollution data will be linked to geocoded addresses and electronic medical records in the Kaiser Permanente Northern California database. We will estimate the relationship between differences in traffic-related air pollution levels and health disparities across multiple disease areas.
Investigator: Van Den Eeden, Stephen
Funder: Environmental Defense Fund
Evaluating a Risk Prediction Model for Lung Cancer
Screening with low-dose computed tomography (LDCT) presents an opportunity to improve early detection and reduce mortality from lung cancer. However, the potential harms of LDCT screening, including frequent false-positive findings that lead to unnecessary procedures and repeated radiation exposure, have raised concerns. Implementing targeted screening of persons at highest predicted risk for lung cancer may minimize such harms, but empirical evidence to support more personalized risk-based screening remains limited. This study presents a mentored career development plan encompassing training and research activities for establishing independence as a translational cancer epidemiologist, with a primary focus on early detection and management of lung cancer. The goal of the proposed research is to evaluate whether the most predictive and clinically-oriented risk model for lung cancer to date can be validated, extended and applied to aid decision-making about LDCT screening.
Investigator: Sakoda, Lori
Funder: National Cancer Institute
Impact of Low IL-10 Levels at Birth and Leukemia Risk
The objectives of this retrospective cohort study of an established case-control study of childhood leukemia are to understand the relationships among immune status at birth, infectious exposures during childhood, and leukemogenesis, and to use this understanding to decrease the incidence of childhood acute lymphoblastic leukemia (ALL). The aims are to: 1) Assess whether a low interleukin-10 level at birth is associated with an increased incidence of early infections characterized by severe clinical symptoms from medical records and self-report; and 2) Determine whether decreased interleukin-10 can contribute to increased ALL in the setting of immune system activation.
Investigator: Kwan, Marilyn
Funder: National Cancer Institute
Risk of Pediatric and Adolescent Cancer Associated with Medical Imaging
The aims of this multiple PI grant are to: 1) Evaluate patterns of medical imaging (utilization and radiation dose) and estimate cumulative exposure to ionizing radiation from medical imaging in a) children (0-18 years old) and b) pregnant women, from 1996-2016; 2) Determine the risk of childhood leukemia among children and adolescents following exposure to all medical imaging examinations that deliver ionizing radiation from 1996-2016 and followed through 2017. We will also examine effects due to exposure from CT exams alone; 3) Determine the risk of childhood cancers among children and adolescents following fetal, in utero (maternal pregnancy) exposure to medical imaging from 1996-2016 followed through 2017; 4) In the subset of the population with complete information during in utero and child or adolescent exposure to medical imaging, assess the cumulative impact of these exposures on childhood cancers.
Investigator: Kwan, Marilyn
Funder: National Cancer Institute
Social Networks, Breast Cancer Treatment and Survival
The research goal is to better understand how breast cancer patients’ social networks influence breast cancer treatment and prognosis. Aims are to: 1) evaluate associations of social network size, types and diversity of network members, and levels of social support, and time to and adherence with breast cancer treatment in the Pathways cohort of stage I-IV breast cancer patients; 2) evaluate associations of social networks and breast cancer recurrence and mortality; and 3) develop, pilot, evaluate, and refine a brief “social networks as a vital sign” (SVS) questionnaire in breast cancer patients at the Kaiser Permanente Oakland Medical Center.
Investigator: Kroenke, Candyce
Funder: National Cancer Institute
Retrospective Validation of MeScore for Identification of Colorectal Cancer
The purpose of this study is to assess the efficacy of the computational method MeScore CRC in risk stratification for colorectal cancer in a seemingly healthy population (average risk).
Investigator: Corley, Douglas
Funder: Medial Research
Effectiveness of Screening Colonoscopy in Reducing Deaths from Colorectal Cancer (SCOLAR)
A case-control study to evaluate the associations between commonly performed tests (e.g. colonoscopy) and mortality from colon cancer.
Investigator: Corley, Douglas
Funder: National Cancer Institute
WHI Cancer Survivor Cohort
The primary goal of this research project is to create an infrastructure within WHI to build a resource for the study of molecular epidemiology and cancer survivorship. Cancer survivors will be followed annually with surveys; tumor tissue will be acquired; and methodological studies will be established to develop electronic linkages with HMO and Medicare data for treatment and outcomes.
Investigator: Caan, Bette
Funder: National Cancer Institute
Diet and Lifestyle in a Prospective Study of Bladder Cancer Survivors
This study involves a new prospective cohort of more than 1,800 non-muscle invasive bladder cancer cases to investigate the role of cruciferous vegetable intake, along with associated individual genetic profiles, on reducing recurrence and progression of disease and improving the efficacy of current treatment modalities.
Investigator: Kwan, Marilyn
Funder: National Cancer Institute
Lifestyle and Molecular Factors of Bone Health in Breast Cancer Survivors
This project will investigate the impact of modifiable lifestyle factors, germline genetic variations, and serum biomarkers, on adverse skeletal outcomes among aromatase inhibitor users, as well as develop a prediction model for risk of fractures for postmenopausal breast cancer patients taking aromatase inhibitors.
Investigator: Kwan, Marilyn
Funder: National Cancer Institute
Early Life Determinants of Accelerated Pubertal Development in Adolescent Girls
The goal of this research is to identify early life factors which influence the timing of pubertal development among adolescent girls. The first study utilizes data from the Cohort Study of Young Girls Nutrition, Environment and Transitions (CYGNET), which has been collecting detailed data on pubertal development, behavioral, environmental, and anthropometric information among 444 adolescent girls since 2005. The second study is a prospective cohort study of approximately 10,000 adolescent girls (age 8-9) within the Kaiser Permanente Northern California population. We will use Tanner stage information that has been entered into HealthConnect to identify early life risk factors of early pubertal development as well as racial/ethnic differences in the timing of pubertal development.
Investigator: Kubo, Ai
Funder: National Cancer Institute
Optimizing Colonoscopy and Fecal Immunochemical Tests for Community-Based Screening, COLOFIT(S)
An evaluation of the entire colorectal cancer screening process to optimize end results. The study includes evaluation of screen-failures (persons who had cancer detected outside of screening), failures of colonoscopy detection (and causes), and differences between screen detected and non-screen detected cancers.
Investigator: Corley, Douglas
Funder: National Cancer Institute
Urinary Diversion Among Bladder Cancer Survivors: Cost, Complications and QOL
This mixed-method, comparative effectiveness study will compare costs, complications, patient- and family-centered outcomes related to urinary diversion. Study participants will include bladder cancer patients undergoing cystectomy and their family caregivers within three Kaiser Permanente regions with a membership base of over six million enrollees.
Investigator: Kwan, Marilyn
Funder: National Cancer Institute
MsFLASH: Living a Healthy Menopause
The aims of this study are: 1) Conduct a 4-arm, double-blind, placebo-controlled randomized trial among postmenopausal women with vaginitis symptoms (moderate/severe vaginal dryness, burning, itching, pain or dyspareunia in the absence of infection) to compare the efficacy of: (a) the probiotic Lactin V, (b) ultra-low dose vaginal estrogen, (Vagifem 10 mcg), and (c) the combination of Lactin V + Vagifem to (d) matching placebos for relief of vaginitis symptoms after 8 weeks of treatment using the most bothersome symptom score as the primary trial outcome. 2) Using the cases recruited for the trial and a group of matched controls (women without symptoms of postmenopausal vaginitis), conduct a case-control study to determine whether patterns of vaginal bacterial colonization, such as pro-inflammatory anaerobic species, differ among women with and without symptoms of postmenopausal vaginitis.
Investigator: Caan, Bette
Funder: National Institute on Aging
Identification of DNA Methylation Markers for Risk of Metastasis in Localized Prostate Cancer
The overarching goal of this study is to develop DNA methylation marker-based prediction algorithms that will pave the way for individualized management strategies for men with localized PCa. To achieve this goal, we propose a nested case-control study based on over 6,500 untreated men to evaluate the prognostic utility of DNA methylation markers measurable from diagnostic PCa biopsy specimens, and to develop and validate a prediction model for 10-year risk of metastasis in localized PCa. This is a study of KPSC and KPNC men with prostate cancer.
Investigator: Van Den Eeden, Stephen
Funder: National Cancer Institute
Exploring the Role of Sarcopenia in Obesity and Breast Cancer Survival
The aim of this study is to gain a better understanding of the role of sarcopenia and body composition in the relationship between obesity and risk of breast cancer progression. We propose to use existing CT scans performed as a part of regular clinical care in this novel application to examine: 1) levels of fat and muscle mass among newly diagnosed breast cancer patients to determine prevalence of sarcopenia among underweight, normal weight, overweight, mildly obese and morbidly obese breast cancer survivors; 2) relationships between categories of fat mass and lean muscle mass at diagnosis (including sarcopenic obesity) and breast tumor characteristics predictive of risk of recurrence and death including disease stage, subtype (ER, PR, and Her2 Neu status), and proliferation markers, 3) relationships between body composition and chemotoxicity; and 4) associations between categories of fat mass and muscle mass and breast cancer-specific and overall mortality.
Investigator: Caan, Bette
Funder: National Cancer Institute
A New Lab-Based Algorithm for HCC Surveillance in Patients with Cirrhosis
The objective of this study is to optimize and test the predictive value of a model in predicting the occurrence of HCC and the performance characteristics of cancer screening tests among patients with cirrhosis and hepatitis C infection.
Investigator: Corley, Douglas
Funder: National Cancer Institute
Adult Life Predictors of Genitourinary Disorders
Investigator: Van Den Eeden, Stephen
Funder: National Institute of Diabetes and Digestive and Kidney Diseases
Long-Term, Prospective, Observational Study of the Risk of Cancer Among Pantoprazole (Protonix) Users
The objective of this study is to determine if there is an increased risk of cancer with pantoprazole (Protonix®), relative to other proton pump inhibitors.
Investigator: Corley, Douglas
Funder: Wyeth-Lederle S.p.A.
