Infrastructure for Pathways, a Prospective Study of Breast Cancer Survivorship

 描述（由申请人提供）：路径研究是一项前瞻性队列研究，研究对象为在Kaiser Permanente北方加州（KPNC）医疗保健系统中诊断为首次原发性浸润性乳腺癌的女性。从2006年1月到2013年5月，该队列中的4，505名女性在种族和民族上各不相同，包括358名（8.0%）非洲裔美国人，557名（12.4%）拉丁裔和578名（12.8%）亚洲女性。 数据已收集的食物摄入量，体力活动，使用营养补充剂和补充和替代方式（CAM），和病人报告的因素，如生活质量，社会支持，医患沟通。从几乎所有队列成员中采集并储存在Roswell Park Cancer Institute（RPCI）研究生物储存库中的生物标本包括血液（n= 4，034，或队列的90%），唾液（n= 4，310，或96%）和提取的生殖系DNA（n= 4，437，或99%）。基线地址已被地理编码，并链接到上下文数据库，以创建社区一级的社会和建筑环境变量。KPNC设置提供了对电子病历（EMR）的访问，其中包括关于诊断特征、治疗（如特定化疗药物和剂量）、激素治疗、高级别毒性和共病状况的数据。截至2014年12月31日，在该队列中确定了369例复发，213例第二原发性浸润性癌症和469例死亡，其中751例女性至少具有其中一种结局。 在这个基础设施补助金，我们建议维持和扩大路径研究，以支持一个不断增长的研究计划，建立在这个资源。将通过KP病历和年度随访问卷继续随访研究受试者的结局。对于尚未通过该里程碑的患者，将继续随访更新的生活质量和其他患者报告的指标，如生活方式因素的变化，直至入组后96个月。我们将增加生物标本资源，随访血液样本用于长期分子因子的检查，建立所有队列成员的肿瘤标本库，并通过免疫组化检测对肿瘤进行亚型分析。我们将通过与KP电子病历数据库的持续链接来增强数据资源;通过整合从遗传疾病研究中心获得的基因型数据（单独拨款获得的影响评分为23）;以及通过更新队列的背景数据。 我们将建立一个外部咨询委员会和一个社区和参与者咨询委员会，以帮助指导基础设施活动，并优先考虑这一群体的研究使用。我们还将建立一个乳腺癌预后流行病学队列研究联盟，以提高检查乳腺癌亚组相关性的能力。持续的支持将加强独特和杰出的资源，即路径研究，并促进其提供给更广泛的研究界。

 DESCRIPTION (provided by applicant): The Pathways Study is a prospective cohort study of women diagnosed with first primary invasive breast cancers in the Kaiser Permanente Northern California (KPNC) medical care system. Enrolled from January, 2006 through May, 2013, the 4,505 women in the cohort are diverse racially and ethnically, and include 358 (8.0%) African American, 557 (12.4%) Latina, and 578 (12.8%) Asian women. Data have been collected on food intake, physical activity, use of nutritional supplements and complementary and alternative modalities (CAM), and patient-reported factors such as quality of life, social support, and doctor-patient communications. Biospecimens collected from almost all cohort members and banked in the study biorepository at Roswell Park Cancer Institute (RPCI) include blood (n=4,034, or 90% of the cohort), saliva (n=4,310, or 96%), and extracted germline DNA (n=4,437, or 99%). Baseline addresses have been geocoded and linked to contextual databases to create neighborhood-level social and built environment variables. The KPNC setting provides access to electronic medical records (EMRs), with data available on diagnostic characteristics, treatment such as specific chemotherapy agents and doses, hormone therapy, high-grade toxicities, and comorbid conditions. As of December 31, 2014, 369 recurrences, 213 second primary invasive cancers, and 469 deaths have been identified in this cohort, with 751 women with at least one of these outcomes. In this infrastructure grant, we propose to maintain and augment the Pathways Study to support a growing research program that builds upon this resource. Study participants will continue to be followed for occurrence of outcomes through KP medical records and annual follow-up questionnaires. Follow-up for updated quality-of-life and other patient-reported measures such as changes in lifestyle factors will continue through 96 months post-enrollment for those who have not yet passed that milestone. We will augment biospecimen resources with a follow-up blood sample for examination of long-term molecular factors, establishing a tumor specimen bank from all cohort members, and by immunohistochemistry assays to subtype tumors. We will enhance data resources with ongoing linkage with databases from KP electronic medical records; by incorporating genotypic data to be obtained from the Center for Inherited Disease Research (separate grant received an Impact Score of 23); and by updating contextual data for the cohort. We will establish an external advisory board and a community and participant advisory board to help guide infrastructure activities and prioritize research use of this cohort. We will also establish a consortium of breas cancer prognosis epidemiology cohort studies to enhance the ability to examine associations in subgroups of breast cancers. Ongoing support will enhance the unique and outstanding resource that is the Pathways Study, and facilitate its availability for the broader research community.