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 Pathways 研究是一项前瞻性队列研究，对象是诊断为首次原发性侵袭性癌症的女性北加州凯撒医疗机构 (KPNC) 医疗保健系统中的乳腺癌治疗。注册自从 2006 年 1 月到 2013 年 5 月，该队列中的 4,505 名女性具有不同的种族和民族，并且其中包括 358 名 (8.0%) 非洲裔美国人、557 名 (12.4%) 拉丁裔女性和 578 名 (12.8%) 亚裔女性。收集了有关食物摄入、体力活动、营养补充剂的使用和补充和替代模式 (CAM) 以及患者报告的因素，例如生活质量、社交支持和医患沟通。从几乎所有队列成员收集的生物样本罗斯威尔公园癌症研究所 (RPCI) 的研究生物储存库中储存的血液包括血液（n=4,034，或 90% 队列）、唾液（n=4,310 或 96%）以及提取的种系 DNA（n=4,437 或 99%）。基线地址已进行地理编码并链接到上下文数据库，以创建邻里级别的社交和建筑环境变量。 KPNC 设置提供对电子病历 (EMR) 的访问，其中包含数据可用于诊断特征、治疗，例如特定化疗药物和剂量、激素治疗、高度毒性和合并症。截至 2014 年 12 月 31 日，复发 369 例，213 例第二原发性浸润性癌症，该队列中已确定 469 例死亡，其中 751 名女性患有这些结果中至少有一个。在这笔基础设施拨款中，我们建议维持和扩大途径研究，以支持以此资源为基础不断发展的研究计划。研究参与者将继续被跟踪通过 KP 医疗记录和年度随访调查问卷了解结果的发生情况。后续行动将继续更新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对于尚未通过该里程碑的人，可在注册后 96 个月内进行。我们将增强生物样本资源以及用于检查长期分子因素的后续血液样本，建立所有队列成员的肿瘤样本库，并通过免疫组织化学分析确定亚型肿瘤。我们将通过与KP电子医疗数据库的持续链接来增强数据资源记录；通过合并从遗传性疾病研究中心获得的基因型数据（单独的资助获得的影响分数为 23）；并更新该群体的背景数据。我们将建立一个外部顾问委员会以及一个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群体的研究用途。我们还将成立一个联盟乳腺癌预后流行病学队列研究，以增强检查相关性的能力乳腺癌的亚组。持续的支持将增强独特而优秀的资源，即途径研究，并促进其为更广泛的研究界所利用。