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：
9044480
负责人：
Christine B. Ambrosone
金额：
$ 197.53万
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/9044480
关键词：
Address African American Aliquot Alternative Therapies Ancillary Study Area Asians Biological Biological Assay Biological Markers 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 Communication Communities Complementary therapies Computerized Medical Record DNA Data Data Collection Databases Diagnosis Diagnostic Disease Dose Eating Enrollment Epidemiology Epidermal Growth Factor Receptor Event Future General Population Genotype Grant Health Planning Immunohistochemistry Infrastructure Activities Inherited Institution Investigation Latina Life Style Link Malignant Neoplasms Mammary Neoplasms Measures Medical Medical Records Modality Molecular Neighborhoods Outcome Participant Pathologic Pathology Pathway interactions Patient Self-Report Patients Pharmaceutical Preparations Physical activity Plasma Procedures Prospective Studies Provider Psychosocial Factor Quality Control Quality of life Questionnaires Records Recurrence Reporting Research Research Infrastructure Research Personnel Research Project Grants Resources Roswell Park Cancer Institute Saliva Sampling Schedule Social Environment Social support Specimen Staining method Stains Subgroup Time Tissue Microarray Toxic effect Translating Tumor Subtype Update Whole Blood Woman base biobank built environment cancer subtypes care systems chemotherapy cohort contextual factors design dietary supplements ethnic diversity exome follow-up genome-wide hormone therapy interest lifestyle factors malignant breast neoplasm member programs prospective public health relevance racial diversity tumor virtual

项目摘要

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.

描述（由适用提供）：途径研究是一项前瞻性队列研究，对在Kaiser Permanente北加州（KPNC）医疗系统中被诊断出患有初次侵入性乳腺癌的妇女。从2006年1月到2013年5月招募，该队列中的4,505名妇女在种族上是多样的，包括358（8.0％）非洲裔美国人，557（12.4％）拉丁裔和578（12.8％）（12.8％）亚裔妇女。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完整性和替代方式（CAM）的数据，以及患者报告的因素，例如生活质量，社会支持和医生沟通。罗斯威尔公园癌症研究所（RPCI）的研究生物库中收集的生物辅助剂，包括血液（n = 4,034，占同伴的90％），唾液（n = 4,310，或96％），以及提取的生育DNA DNA（n = 4,437，4,437，或999％）。基线地址已被解编码，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，并提供有关诊断特征的数据，例如特定的化学疗法和剂量，马龙治疗，高级毒性和合并症。截至2014年12月31日，在该队列中发现了369次回报，213次主要入侵癌和469例死亡，其中751名女性至少有其中一个结果。在这项基础设施赠款中，我们建议维护和扩大途径研究，以支持基于此资源的不断增长的研究计划。通过KP病历和年度随访问卷，将继续遵循研究参与者的结果。为那些尚未通过该里程碑的人，对更新的生活质量和其他患者报告的措施（例如生活方式因素变化）的后续措施将持续到注册后96个月。我们将使用随访的血液样本来增强生物循环资源，以检查长期分子因素，从所有队列成员以及通过免疫组织化学化合物到亚型肿瘤建立肿瘤标本库。我们将通过与KP电子医疗记录的数据库进行持续联系来增强数据资源；通过合并从遗传疾病研究中心获得的基因型数据（单独的赠款得到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和社区和参与咨询委员会，以帮助指导基础设施活动并确定对该队列的研究使用。我们还将建立一个癌症预后流行病学队列研究的联盟，以增强检查乳腺癌亚组相关的能力。持续的支持将增强途径研究的独特而杰出的资源，并促进其对更广泛的研究社区的可用性。