Infrastructure for Pathways, a Prospective Study of Breast Cancer Survivorship

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ABSTRACT The Pathways Study is a prospective cohort study of women diagnosed with first primary invasive breast cancer in the Kaiser Permanente Northern California (KPNC) health care system. Enrolled from January 2006 through May 2013, the 4,505 women in the cohort are racially and ethnically diverse, and include 351 (7.8%) African American, 512 (11.4%) Latina, and 599 (13.3%) Asian women. Data have been collected on food intake, physical activity, use of nutritional supplements and complementary and alternative therapies, and quality of life, social support, doctor-patient communications, and other factors. We have banked biospecimens at Roswell Park Comprehensive Cancer Center including blood (n=4,034, or 90% of the cohort), saliva (n=4,310, or 96%), and extracted germline DNA (n=4,437, or 99%), and have conducted genome-wide assays through the NIH Center for Inherited Disease Research program. We have established a biorepository of slides and tumor blocks from initial surgery (n=4,150, or 92%). We have also geocoded baseline addresses and linked these data to contextual databases to create neighborhood-level social and built environment variables. The KPNC setting provides access to electronic health records (EHRs), and we have detailed data available on diagnostic characteristics, treatment regimens, high-grade toxicities, and comorbid conditions. As of February 24, 2020, 572 recurrences, 424 second primary invasive cancers, and 886 deaths have been identified, with 1,286 women with at least one of these outcomes. In this infrastructure competitive renewal application, we propose to maintain and augment the Pathways Study to support research questions that build upon this resource. Study participants will continue to be followed for updates and outcomes through biennial follow-up questionnaires. We will maintain our biorepositories at Roswell Park and KPNC, and expand our tumor specimen bank by collecting slides and tumor blocks from ~600 recurrences. We will enhance our data resources with ongoing linkage with the KPNC EHR, and establish new linkages with geospatial environmental exposure databases and California statewide data on hospitalizations, emergency department visits, and ambulatory surgery. To address relevance to changes in breast cancer treatment and care, we will complement the cohort by establishing a data-only cohort of about 48,000 invasive breast cancer cases diagnosed and treated in KPNC from 2006-2023, will extract data from the KPNC EHR, and link to geospatial and statewide health care data, as with the Pathways Study. We will continue engagement with our External Advisory Board and Community Advisory Board to help guide infrastructure activities and prioritize research use of this cohort. We will also create a Pathways Study data enclave that will enable investigators to readily explore data and biospecimen availability for analyses or research projects. Continued support will enhance this unique, outstanding, multi-level, multi-dimensional, innovative resource, and facilitate its availability for the broader research community.