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

基本信息

批准号：
10081095
负责人：
Christine B. Ambrosone
金额：
$ 17.07万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-06-01 至 2021-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10081095
关键词：
Address African American Aliquot Alternative Therapies Ancillary Study Area Asians Biological Biological Assay Biological Markers Biological Specimen Banks Blood Blood specimen Breast Cancer Patient Breast Cancer survivor Breast Cancer survivorship California Cancer Prognosis Cessation of life Characteristics Chemotherapy-Oncologic Procedure Cohort Studies Collaborations Communities Complementary therapies Computerized Medical Record DNA Data Data Collection Databases Diagnosis Diagnostic Dose Eating Enrollment Epidemiology Epidermal Growth Factor Receptor Estrogen receptor positive Event Follow-Up Studies Future General Population Genotype Grant Hereditary Disease Immunohistochemistry Infrastructure Infrastructure Activities Institution Investigation Latina Life Style Link Mammary Neoplasms Medical Medical Records Modality Molecular Neighborhoods Outcome Participant Pathologic Pathology Pathway interactions Patient Outcomes Assessments Patient Self-Report Patients Pharmaceutical Preparations Physical activity Plasma Procedures Prospective Studies Prospective cohort study Provider Psychosocial Factor Quality Control Quality of life Questionnaires Records Recurrence Reporting Research Research Personnel Research Project Grants Research Support Resources Roswell Park Cancer Institute Saliva Sampling Schedule Social Environment Social support Specimen Stains Subgroup Time Tissue Microarray Toxic effect Translating Tumor Subtype Update Whole Blood Woman biobank built environment cancer invasiveness cancer subtypes care systems chemotherapy cohort comorbidity contextual factors data cleaning data resource design dietary supplements electronic data ethnic diversity exome follow-up genome-wide health plan hormone therapy interest lifestyle factors malignant breast neoplasm member patient subsets patient-clinician communication programs public health relevance racial and ethnic racial diversity tumor virtual

项目摘要

ABSTRACT 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 breast 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.

抽象的途径研究是一项前瞻性队列研究，对被诊断为初次侵入性的妇女 Kaiser Permanente北加州（KPNC）医疗系统中的乳腺癌。从 2006年1月至2013年5月，该队列中的4,505名妇女在种族和种族上是多种多样的，并且包括358（8.0％）非裔美国人，557（12.4％）拉丁裔和578（12.8％）亚洲妇女。已经收集了有关食物摄入，体育锻炼，营养补充剂的使用以及互补和替代方式（CAM）以及患者报告的因素，例如生活质量，社会支持和医生沟通。从几乎所有队列成员那里收集的生物测量和在罗斯威尔公园癌症研究所（RPCI）的研究生物库中存入了研究，包括血液（n = 4,034，或90％的血液队列），唾液（n = 4,310，或96％），并提取种系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，以创建社区级别的社交和构建环境变量。 KPNC设置提供了对电子病历（EMR）的访问，并提供数据可用于诊断特征，例如特定化学疗法和剂量，激素等治疗治疗，高级毒性和合并症。截至2014年12月31日，369次复发，213 在该队列中发现了第二次主要侵入性癌症和469例死亡，有751名妇女这些结果中至少有一个。在这项基础设施赠款中，我们建议维护和扩大途径研究，以支持不断发展的研究计划以此资源为基础。学习参与者将继续遵循通过KP病历和年度后续调查表的结果发生。后续更新的生活质量和其他患者报告的措施，例如生活方式因素的变化将继续在注册后96个月内，尚未通过该里程碑的人。我们将增加带有后续血液样本的生物循环资源，用于检查长期分子因素，建立所有队列成员的肿瘤标本库，并通过免疫组织化学分析到亚型肿瘤。我们将通过与KP电子医疗的数据库进行持续联系来增强数据资源记录；通过合并从遗传疾病研究中心获得的基因型数据（单独的赠款获得23的影响得分）；并通过更新队列的上下文数据。我们将建立外部顾问委员会以及社区和参与者顾问委员会来帮助指导基础设施活动并优先考虑该队列的研究使用。我们还将建立一个财团乳腺癌的预后流行病学队列研究增强了检查关联的能力乳腺癌的亚组。持续的支持将增强独特而杰出的资源途径研究，并促进其对更广泛的研究社区的可用性。