PCPT and SELECT Cohorts: Core Infrastructure Support for Cancer Research

PCPT 和 SELECT 队列：癌症研究的核心基础设施支持

• 批准号: 10227705
• 负责人: IAN M. THOMPSON
• 金额: $ 65.32万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10227705
• 关键词: Address; Adverse event; African American; Age; Age related macular degeneration; Aging; Alzheimer' s Disease; American Medical Association; Ancillary Study; Androgen Metabolism; Atrophic; Biological; Biopsy; Blood; Cancer Research Infrastructure; Cardiovascular system; Cataract; Cause of Death; Cessation of life; Clinical; Clinical Trials Design; Collaborations; Colorado; Colorectal; Colorectal Cancer; Colorectal Polyp; Controlled Clinical Trials; Country; Data; Data Collection; Data Element; Data Linkages; Data Set; Databases; Diagnosis; Diet; Disease; Documentation; Double-Blind Method; Double-blind trial; Etiology; Finasteride; Funding; Genotype; Grant; Incidence; Inflammation; Infrastructure; Institution; Insulin Resistance; Journals; Leukocytes; Life Style; Malignant Neoplasms; Malignant neoplasm of lung; Malignant neoplasm of prostate; Measures; Medical History; Medicare; Medicine; Minority; National Clinical Trials Network; New England; Participant; Pathology; Pharmaceutical Preparations; Phase; Physical activity; Placebos; Plasma; Procedures; Prognosis; Program Research Project Grants; Prostate; Prostate Cancer Prevention Trial; Prostate-Specific Antigen; Publications; Publishing; Quality of life; Randomized; Randomized Clinical Trials; Reporting; Research Design; Research Personnel; Respiratory physiology; Risk; Risk Factors; Sampling; Schedule; Screening for Prostate Cancer; Secure; Selenium; Selenium and Vitamin E Efficacy Trial; Serum; Southwest Oncology Group; Specimen; Structure of nail of toe; Tissue Banks; Tissue Sample; Tissues; United States; Universities; Update; Visit; Vitamin E; Washington; anticancer research; arm; biobank; cancer diagnosis; cancer epidemiology; clinical database; cohort; data dictionary; data repository; data sharing; dietary supplements; digital; epidemiology study; follow-up; genetic association; genome wide association study; genome-wide; indexing; lower urinary tract symptoms; male; member; men; oxidative damage; placebo controlled study; placebo group; prospective; prostate biopsy; prostate cancer risk; randomized trial; rectal; repository; secondary endpoint; statistical center; user-friendly

PROJECT SUMMARY/ABSTRACT The SWOG Statistical Center in Seattle, Washington, served as the coordinating center for two large prostate cancer prevention trials: The Selenium and Vitamin E Cancer Prevention Trial (SELECT) and the Prostate Cancer Prevention Trial (PCPT). SELECT was a Phase III, double-blind, placebo-controlled study designed to assess the effect of selenium and vitamin E, alone and in combination, primarily on prostate cancer incidence and secondarily on other cancer incidence. SELECT randomized 35,533 men between 2001 and 2004. PCPT, also a Phase III, double-blind trial, randomized 18,882 men to either finasteride or placebo between 1994 and 1997. Although schedules and requirements varied between the two studies, substantial serum, plasma, white blood cells, and prostate tissue were collected on both, resulting in rich biorepositories. Each had extensive prospective data collections which included diet and dietary supplements, quality of life, physical activity, medications, other cancer diagnoses, cardiovascular endpoints, and treatment adverse events. Although there have been significant scientific collaborations to date, there remain numerous opportunities to further interrogate the clinical database and biobanks. Additionally, serum and plasma measures and extensive genotyping data have already been obtained and are available for other investigators to use. These cohorts are fully mature with 6,045 deaths and median follow-up of 18.4 years on PCPT and 3,762 deaths and median follow-up of 10.1 years on SELECT. There have been 2,401 and 2,475 prostate cancers detected during the trials plus an additional 890 and 338 prostate cancers identified via Medicare linkage in PCPT and SELECT, respectively. Other primary cancers have also been documented either during the trials or through data linkage. In addition to being able to extend the results of these well-conducted, randomized clinical trials through linkages to Medicare, NDI and completed GWAS studies, these data can be used for epidemiologic research as part of the ongoing consortium projects. We request funds to continue to enrich the cohorts by collecting new data elements such as end point data from Medicare and National Death Index linkages. We plan to update our linkages early in the upcoming grant period. We also request support for the cohort team to develop detailed documentation and data sets to load into the Cancer Epidemiology Data Repository, and we ask for continued support to provide a stable infrastructure for the PCPT serum and PCPT and SELECT tissue repositories (all located at the University of Colorado). With continued funding for the Statistical Center and some of our key scientific colleagues, we will be able to provide administrative assistance and expertise to investigators who apply for additional funding to conduct studies using our rich biologic repositories and clinical databases from PCPT and SELECT.

项目总结/摘要 位于华盛顿西雅图的SWOG统计中心作为两个大型前列腺增生症的协调中心， 癌症预防试验：硒和维生素E癌症预防试验（SELECT）和前列腺 癌症预防试验（PCPT）。SELECT是一项III期、双盲、安慰剂对照研究， 评估硒和维生素E单独或联合使用对前列腺癌发病率的影响 其次是其他癌症的发病率。SELECT在2001年至2004年期间随机分配了35，533名男性。PCPT， 这也是一项III期双盲试验，在1994年至2005年期间，将18，882名男性随机分为非那肽组或安慰剂组。 1997.尽管两项研究的时间表和要求不同，但大量血清、血浆、白色 血细胞和前列腺组织被收集在两者上，产生丰富的生物储存库。 每个人都有广泛的前瞻性数据收集，包括饮食和膳食补充剂，生活质量， 体力活动、药物治疗、其他癌症诊断、心血管终点和治疗不良事件。 虽然迄今为止已经有了重要的科学合作，但仍然有许多机会， 进一步查询临床数据库和生物库。此外，血清和血浆测量和广泛的 基因分型数据已经获得，可供其他研究人员使用。 这些队列完全成熟，有6，045例死亡，PCPT的中位随访时间为18.4年，有3，762例死亡 中位随访时间为10.1年。分别检测出2,401例和2,475例前列腺癌 在试验期间，通过PCPT中的医疗保险联系确定了另外890和338例前列腺癌， 分别选择。其他原发性癌症也在试验期间或通过 数据连接除了能够扩展这些进行良好的随机临床试验的结果之外 通过与医疗保险、NDI和已完成的GWAS研究的联系，这些数据可用于流行病学研究。 研究作为正在进行的财团项目的一部分。 我们要求拨款，继续通过收集新的数据元素，如终点数据， 医疗保险和国家死亡指数的联系。我们计划在即将到来的赠款期间尽早更新我们的联系。 我们还请求支持队列团队开发详细的文档和数据集，以加载到 癌症流行病学数据库，我们要求继续提供支持，为以下方面提供稳定的基础设施： PCPT血清以及PCPT和SELECT组织储存库（均位于科罗拉多大学）。与 继续资助统计中心和我们的一些关键科学同事，我们将能够提供 为申请额外资金以使用 我们丰富的生物资源库和临床数据库来自PCPT和SELECT。