Infrastructure for Pathways, a Prospective Study of Breast Cancer Survivorship

通路基础设施，乳腺癌存活率的前瞻性研究

• 批准号: 10439575
• 负责人: Christine B. Ambrosone
• 金额: $ 192.03万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10439575
• 关键词: Accident and Emergency department; Address; African American; Air; Aliquot; Alternative Therapies; Ambulatory Surgical Procedures; Ancillary Study; Asian; Behavior; Biological Assay; Biological Specimen Banks; Blood; Blood specimen; Breast Cancer Treatment; Breast Cancer survivorship; California; Cancer Prognosis; Cardiovascular Diseases; Cessation of life; Characteristics; Clinical; Cohort Studies; Communities; Complement; Complementary therapies; Comprehensive Cancer Center; DNA; DNA Microarray Chip; Data; Data Linkages; Databases; Diagnosis; Diagnostic; Dimensions; Dose; Eating; Electronic Health Record; Emergency department visit; Enrollment; Environment; Environmental Exposure; Epidemiology; Event; Formalin; Health; Healthcare; Healthcare Systems; Hereditary Disease; Hospitalization; Infrastructure; Infrastructure Activities; Institution; Integrated Health Care Systems; Latina; Life Style; Link; Management Information Systems; Measures; Medical; Molecular; Molecular Genetics; Neighborhoods; Operative Surgical Procedures; Outcome; Paraffin Embedding; Participant; Pathologic; Pathway interactions; Patient Self-Report; Patients; Pharmaceutical Preparations; Physical activity; Plasma; Prospective Studies; Prospective cohort study; Quality of life; Questionnaires; Recurrence; Reporting; Research; Research Personnel; Research Project Grants; Research Support; Resources; Saliva; Slide; Social Environment; Social Network; Social support; Specimen; Time; Tissue Microarray; Toxic effect; Treatment Protocols; Tumor Bank; United States National Institutes of Health; Update; Whole Blood; Woman; base; biobank; bone health; breast cancer diagnosis; built environment; cancer care; cancer invasiveness; cancer therapy; care systems; chemotherapy; cohort; comorbidity; cost; data enclave; data resource; design; dietary supplements; epidemiology study; ethnic diversity; experience; follow-up; genome-wide; health care service utilization; health plan; improved; innovation; lifestyle factors; malignant breast neoplasm; member; multi-ethnic; patient-clinician communication; programs; racial diversity; saliva sample; tumor; virtual; water quality; web portal

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.

摘要 Pathways研究是一项对首次诊断为原发性浸润性乳腺癌的女性进行的前瞻性队列研究 凯萨医疗机构北方加州（KPNC）医疗保健系统中的癌症。从2006年1月起入学 截至2013年5月，该队列中的4，505名女性具有种族和民族多样性，其中包括351名（7.8%） 非裔美国人，512名（11.4%）拉丁裔和599名（13.3%）亚裔女性。 已经收集了关于食物摄入量、身体活动、营养补充剂的使用以及 补充和替代疗法，生活质量，社会支持，医患沟通， 等因素我们在罗斯威尔公园综合癌症中心储存了生物标本， 血液（n= 4，034，或90%的队列）、唾液（n= 4，310，或96%）和提取的生殖系DNA（n= 4，437，或96%）。 99%），并通过NIH遗传疾病研究中心进行了全基因组分析 程序.我们已经建立了一个生物储存库的载玻片和肿瘤块从最初的手术（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， 社区层面的社会和建成环境变量。KPNC设置提供了访问电子 健康记录（EHR），我们有关于诊断特征，治疗方案， 严重毒性和合并症截至2020年2月24日，572例复发，424例第二原发 已确定886例死亡，其中1 286名妇女至少有上述一种结果。 在此基础架构竞争性更新应用程序中，我们建议维护和增强路径 研究以支持建立在此资源上的研究问题。研究参与者将继续 通过两年一次的后续调查问卷跟踪最新情况和结果。我们将保持我们 在罗斯韦尔公园和KPNC的生物储存库，并通过收集载玻片和 约600例复发的肿瘤块。我们将加强我们的数据资源，与KPNC保持联系 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 关于住院、急诊和门诊手术的数据。为了解决与 乳腺癌治疗和护理的变化，我们将通过建立仅数据队列来补充队列 从2006年至2023年在KPNC诊断和治疗的约48，000例浸润性乳腺癌病例中， 数据从KPNC EHR，并链接到地理空间和全州的医疗保健数据，与路径研究。 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， 指导基础设施活动，优先考虑这一群体的研究用途。我们还将创建一个路径研究 数据飞地，使研究者能够随时探索数据和生物样本的可用性，以进行分析， 研究项目。持续的支持将加强这一独特的，杰出的，多层次，多维度， 创新资源，并促进其提供给更广泛的研究界。