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 路径研究是对被诊断为第一次原发侵袭的妇女进行的前瞻性队列研究 凯撒永久北加州(KPNC)医疗系统中的乳腺癌。注册自 从2006年1月到2013年5月，队列中的4505名女性在种族和民族上是多样化的， 包括358名非裔美国人(8.0%)、557名拉丁裔(12.4%)和578名(12.8%)亚裔女性。 已经收集了关于食物摄入量、体力活动、营养补充剂使用和 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和 Roswell Park癌症研究所(RPCI)的研究生物库中包括血液(n=4,034，或90% 队列)、唾液(n=4,310，或96%)和提取生殖系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，以创建社区级别的社交和构建 环境变量。KPNC设置提供对包含数据的电子病历(EMR)的访问 可用于诊断特征、治疗，如特定的化疗药物和剂量、激素 治疗，高度毒性，以及共病情况。截至2014年12月31日，369次复发，213次 第二种原发浸润性癌症，在这一队列中已确认469人死亡，其中751名妇女患有AT 这些结果中至少有一个。 在这笔基础设施拨款中，我们建议维持和加强路径研究，以支持 在这一资源的基础上不断发展的研究计划。研究参与者将继续接受跟踪调查 通过金伯利进程病历和年度跟踪调查问卷了解结果的发生。跟进以下项目 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，将继续 通过96个月的注册后，对于那些尚未超过这一里程碑的人。我们将增加 具有长期分子因素检查的后续血液样本的生物样品资源， 从所有队列成员中建立肿瘤标本库，并通过免疫组织化学方法进行亚型分析 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；纳入将从遗传病研究中心获得的基因分型数据 (单独赠款的影响得分为23)；以及更新队列的背景数据。 我们将成立一个外部咨询委员会和一个社区和参与者咨询委员会来帮助 指导基础设施活动，并优先使用这一队列的研究。我们还将成立一个财团， 乳腺癌预后流行病学队列研究，以提高检查相关性的能力 乳腺癌的亚组。持续的支持将加强独特和杰出的资源，即 路径研究，并促进其在更广泛的研究社区的可用性。