The Women's Health Study: Infrastructure Support for Continued Cohort Follow-up

妇女健康研究：为持续队列随访提供基础设施支持

• 批准号: 8928572
• 负责人: Julie E. Buring
• 金额: $ 88.5万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-17 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8928572
• 关键词: Address; Ancillary Study; Aspirin; Beta Carotene; Biological Assay; Biological Markers; Blood; Blood specimen; Breast; Cardiovascular Diseases; Cause of Death; Cessation of life; Characteristics; Chronic Disease; Cohort Studies; Collaborations; Colorectal; DNA; Data; Data Quality; Death Certificates; Development; Disease; Dose; Epidemiologic Studies; Erythrocytes; Event; Funding; Future; Gene Frequency; Genes; Genetic; Genotype; Grant; Knowledge; Letters; Life Style; Lung; Malignant Neoplasms; Measurement; Measures; Medical History; Medical Records; Methods; Minor; Morbidity - disease rate; National Cancer Institute; Observational Study; Outcome; Paper; Patient Self-Report; Physical activity; Plasma; Policies; Process; Publishing; Quality Control; Questionnaires; Randomized Controlled Trials; Reporting; Research; Research Activity; Research Infrastructure; Research Personnel; Risk; Role; Sampling; Testing; Time; Translating; U-Series Cooperative Agreements; Update; Validation; Variant; Vitamin E; Woman; Women' s Health; Work; aged; base; cancer epidemiology; cancer prevention; cohort; cost effective; data management; data sharing; exome; follow-up; functional group; gene environment interaction; genetic information; genetic variant; genome wide association study; interest; member; mortality; prevent; rare variant; repository; web site; working group

DESCRIPTION (provided by applicant): The WHS began in 1992 as a randomized controlled trial testing aspirin, beta-carotene, and vitamin E for preventing cancer and cardiovascular disease (CVD) in 39,876 healthy women, aged >45, The trial ended in 2004, and women have been followed observationally since that time. At study entry and annually, women report via questionnaires on a wide range of exposures and endpoints, including cancer and CVD. We confirm these self-reported endpoints with medical records, and cause of death in decedents is ascertained using medical records and death certificates. At baseline, 28,345 women also provided a blood sample, from which plasma, buffy coat, and red blood cells were obtained and stored at -170 �C. GWAS data on common variation are available for all women with blood, measurement of rare variants in exomes have just been completed for >23,000 women; and all samples have been assayed for several biomarkers. Objectively assessed 7-day physical activity by accelerometer is being collected on ~18,000 women. The WHS cohort is unique in having GWAS and objectively-assessed physical activity in such a large cohort. Follow-up is excellent; after almost 20 years, morbidity follow-up is 94 percent; and mortality follow-up is virtually 100 percent. At the end of current funding, 6,086 confirmed cancers (2,440 breast, 583 colorectal, 537 lung, 1,517 cancer deaths) will have occurred. During the proposed funding period, cancer and CVD endpoints will increase by 30 percent and 51 percent. The WHS has actively provided data to internal and external researchers, with 444 papers published, 89 ancillary studies funded, and participation in 19 NCI Cohort Consortium collaborative projects. In the proposed funding period, we intend to: (1) continue to update exposure and endpoint information, and maintain the repository of biospecimens, to further facilitate data sharing and collaboration, and (2) use the WHS infrastructure to address specific aims related to physical activity; evaluate the translational potential of gene-based risk and explore gene-by-environment interactions; and examine long-term chemo-protection of low-dose aspirin on cancer. None of the ancillary studies provides funding for ascertainment and validation of cancer (and CVD) endpoints. Continued infrastructure support and follow-up is crucial for maximizing the cost-effective use of this valuable large-scale cohort of women with a rich bank of already collected phenotypic and genetic data. RELEVANCE: This application seeks support over the next 5 years for the infrastructure of the Women's Health Study, a large-scale cancer epidemiology cohort of 39,876 women followed since 1992, Data are available on a wide range of characteristics, chronic disease development, blood biomarkers, genetic information, and objectively measured physical activity. Continued follow-up is crucial for building on the enormous amount of data already collected in order to answer critical questions related to cancer.

描述（由适用提供）：WHS始于1992年，是一项随机对照试验测试阿司匹林，β-胡萝卜素和维生素E，用于预防癌症和心血管疾病（CVD），39,876名健康妇女，年龄> 45岁，该试验于2004年结束，自那时以来一直在观察到妇女。在研究条目中，妇女每年通过问卷报告各种暴露和终点，包括癌症和CVD。我们确认具有病历的这些自我报告的终点，并使用病历和死亡证书确定死亡原因。在基线时，28,345名妇女还提供了一个血液样本，从中获得了血浆，Buffy Coat和Red Blood细胞，并将其存储在-170°C。所有血液中的女性都可以使用有关常见变异的GWAS数据，刚刚完成了> 23,000名妇女的稀有变体的测量。并且所有样品均已评估了几种生物标志物。通过加速度计，正在对约18,000名女性进行客观评估的7天体育活动。 WHS队列在如此大的队列中具有GWA和客观评估的体育锻炼是独一无二的。随访非常好；经过将近20年后，发病率随访为94％。死亡率随访实际上是100％。在目前的资金结束时，将发生6,086个确认的癌症（2,440乳房，583个结直肠癌，537肺，1,517例癌症死亡）。在拟议的资金期间，癌症和CVD终点将增加30％和51％。 WHS已积极向内部和外部研究人员提供数据，其中有444篇论文，89项辅助研究资助，并参与了19个NCI队列联盟协作项目。在拟议的资金期间，我们打算：（1）继续更新曝光和端点信息，并维护生物测量的存储库，以进一步支持数据共享和协作，（2）使用WHS基础架构来解决与体育活动相关的特定目标；评估基于基因的风险的转化潜力，并探索逐环境的基因相互作用；并检查低剂量阿司匹林对癌症的长期化学保护。没有任何辅助研究为癌症（和CVD）终点的确定和验证提供资金。持续的基础设施支持和随访对于最大程度地利用了这种有价值的大规模妇女的成本效益，并拥有丰富的已经收集的表型和遗传数据。 相关性：该应用程序在未来5年内寻求支持妇女健康研究的基础设施，自1992年以来，癌症流行病学队列的大规模癌症流行病学队列与39,876名妇女相关，可在广泛的特征，慢性疾病发展，血液生物标志物，遗传信息以及客观测量的体育活动上提供数据。持续的随访对于建立已经收集的大量数据以回答与癌症有关的关键问题至关重要。