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: 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
• 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

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.

摘要 路径研究是一项前瞻性队列研究， 乳腺癌在凯撒永久北方加州（KPNC）医疗保健系统。入组 2006年1月至2013年5月，该队列中的4，505名女性在种族和民族方面各不相同， 包括358名（8.0%）非裔美国人、557名（12.4%）拉丁裔和578名（12.8%）亚裔妇女。 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 补充和替代模式（CAM），以及患者报告的因素，如生活质量，社会 支持和医患沟通。从几乎所有队列成员中采集的生物标本， 储存在Roswell Park Cancer Institute（RPCI）研究生物储存库中的血液包括血液（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会和建设 环境变量。KPNC设置提供对电子病历（EMR）的访问， 可获得关于诊断特征、治疗（如特定化疗剂和剂量）、激素 治疗、高级别毒性和共病状况。截至2014年12月31日，369个复发，213个 第二原发性浸润性癌症，469例死亡已确定在这个队列中，有751名妇女， 这些结果中的至少一个。 在这项基础设施拨款中，我们建议维持和扩大路径研究，以支持 不断增长的研究计划，建立在这个资源。研究参与者将继续接受随访， 通过KP医疗记录和年度随访问卷了解结果的发生情况。随访 将继续更新生活质量和其他患者报告的指标，如生活方式因素的变化 对于那些尚未通过该里程碑的人，在入组后96个月内。我们会增加 生物标本资源与后续血液样本检查的长期分子因素， 建立来自所有队列成员的肿瘤标本库，并通过免疫组织化学测定对亚型 肿瘤的我们将通过与KP电子医疗数据库的持续链接来增强数据资源 记录;通过合并从遗传疾病研究中心获得的基因型数据 （单独的补助金获得了23分的影响力分数）;以及更新队列的上下文数据。 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， 指导基础设施活动，优先考虑这一群体的研究用途。我们还将建立一个财团， 乳腺癌预后流行病学队列研究，以提高检查 乳腺癌的亚组。持续的支持将加强独特和杰出的资源， 路径研究，并促进其向更广泛的研究界提供。