Infrastructure for Pathways, a Prospective Study of Breast Cancer Survivorship

摘要 路径研究是一项前瞻性队列研究，研究对象是被诊断为首次乳房侵袭性疾病的女性 北加州凯撒永久医疗保健系统中的癌症。2006年1月起招生 截至2013年5月，队列中的4505名女性在种族和民族方面是多样化的，其中包括351名(7.8%) 非洲裔美国人，512名拉丁裔(11.4%)和599名亚裔女性(13.3%)。 已经收集了关于食物摄入量、体力活动、营养补充剂使用和 补充和替代疗法、生活质量、社会支持、医患沟通、 以及其他因素。我们已经在罗斯威尔公园综合癌症中心储存了生物检验品，包括 血液(n=4,034，或队列的90%)、唾液(n=4,310，或96%)，以及提取的生殖系DNA(n=4,437，或 99%)，并通过美国国立卫生研究院遗传病研究中心进行了全基因组分析 程序。我们已经建立了初始手术的切片和肿瘤块的生物存储库(n=4,150，或 92%)。我们还对基线地址进行了地理编码，并将这些数据链接到上下文数据库以创建 社区层面的社会和已建环境变量。KPNC设置提供对电子 健康记录(EHR)，我们有关于诊断特征、治疗方案、 严重的毒副作用，以及并存的条件。截至2020年2月24日，572例复发，424例二次初选 已确认有886人死于浸润性癌症，其中1 286名妇女至少有一种结果。 在这项基础设施竞争性更新申请中，我们建议维护和增强路径 研究以支持以此资源为基础的研究问题。研究参与者将继续 通过两年一次的后续调查问卷跟踪了解最新情况和结果。我们将维持我们的 罗斯韦尔公园和KPNC的生物库，并通过收集幻灯片和 约600次复发的肿瘤块。我们将通过与KPNC的持续联系来加强我们的数据资源 EHR，并与地理空间环境暴露数据库和加州全州建立新的联系 住院、急诊科就诊和门诊手术的数据。解决与以下问题的相关性 在乳腺癌治疗和护理方面的变化，我们将通过建立仅有数据的队列来补充队列 在2006-2023年KPNC诊断和治疗的约48,000例浸润性乳腺癌病例中，将提取 来自KPNC EHR的数据，并链接到地理空间和全州范围的医疗保健数据，如路径研究。 我们将继续与我们的外部咨询委员会和社区咨询委员会合作，提供帮助 指导基础设施活动，并优先使用这一队列的研究。我们还将创建一项路径研究 数据飞地，使调查人员能够轻松地探索数据和生物样品的可用性，以进行分析或 研究项目。持续的支持将提升这一独特、卓越、多层次、多维度、 创新资源，并为更广泛的研究界提供便利。

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.