PCPT and SELECT Cohorts: Core Infrastructure Support for Cancer Research

项目概要/摘要 位于华盛顿州西雅图的 SWOG 统计中心作为两个大型前列腺的协调中心 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，旨在 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 年间对 35,533 名男性进行了随机分组。PCPT， 这也是一项 III 期双盲试验，在 1994 年至 1997. 尽管两项研究的时间表和要求有所不同，但大量的血清、血浆、白细胞 两者都收集了血细胞和前列腺组织，形成了丰富的生物样本库。 每个人都收集了广泛的前瞻性数据，其中包括饮食和膳食补充剂、生活质量、 体力活动、药物、其他癌症诊断、心血管终点和治疗不良事件。 尽管迄今为止已经开展了重要的科学合作，但仍然存在许多机会 进一步询问临床数据库和生物样本库。此外，血清和血浆测量以及广泛的 基因分型数据已经获得并可供其他研究人员使用。 这些队列已完全成熟，有 6,045 例死亡，PCPT 中位随访时间为 18.4 年，有 3,762 例死亡 SELECT 的中位随访时间为 10.1 年。已检测出 2,401 例和 2,475 例前列腺癌 在试验期间，另外还通过 PCPT 和 Medicare 链接发现了另外 890 例和 338 例前列腺癌 分别选择。其他原发性癌症也已在试验期间或通过 数据联动。除了能够扩展这些进行良好的随机临床试验的结果 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联盟项目的一部分。 我们请求资金通过收集新的数据元素（例如来自以下来源的终点数据）来继续丰富队列： 医疗保险和国家死亡指数的联系。我们计划在即将到来的资助期内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 癌症流行病学数据存储库，我们请求继续支持，为癌症流行病学数据存储库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 继续为统计中心和我们的一些重要科学同事提供资金，我们将能够提供 向申请额外资金进行研究的研究人员提供行政协助和专业知识 我们来自 PCPT 和 SELECT 的丰富的生物资源库和临床数据库。

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.