PCPT and SELECT Cohorts: Core Infrastructure Support for Cancer Research

项目摘要/摘要 位于华盛顿州西雅图的SWOG统计中心作为两个大前列腺的协调中心 癌症预防试验：硒和维生素E癌症预防试验(SELECT)和前列腺癌 癌症预防试验(PCPT)。SELECT是一项第三阶段的双盲安慰剂对照研究，旨在 评估单独和联合应用硒和维生素E对前列腺癌发病率的影响 其次是其他癌症发病率。选择2001至2004年间随机抽取的35,533名男性。PCPT， 同样是一项第三阶段的双盲试验，在1994至1994年间，随机选择18,882名男性服用非那雄胺或安慰剂。 1997年。尽管两项研究的时间表和要求不同，但大量的血清、血浆、白蛋白 血细胞和前列腺组织都被收集在两者上，从而产生了丰富的生物库。 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、其他癌症诊断、心血管终点和治疗不良事件。 尽管到目前为止已经有了重大的科学合作，但仍然有许多机会 进一步询问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，并可供其他调查人员使用。 这些队列完全成熟，有6045人死亡，PCPT的中位随访时间为18.4年，3762人死亡 SELECT的中位随访期为10.1年。已发现2401例和2475例前列腺癌 在试验期间，另外还有890例和338例前列腺癌是通过PCPT和 分别选择。其他原发癌症也被记录在试验期间或通过 数据链接。除了能够扩展这些进行得很好的随机临床试验的结果 通过与Medicare、NDI和已完成的Gwas研究相联系，这些数据可用于流行病学 作为正在进行的联合体项目的一部分进行研究。 我们要求资金继续通过收集新的数据元素来丰富队列，例如来自 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早期更新我们的联系。 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，我们要求继续支持，为以下项目提供稳定的基础设施 PCPT血清和PCPT以及精选组织库(均位于科罗拉多大学)。使用 继续为统计中心和我们的一些关键科学同事提供资金，我们将能够提供 向申请额外资金进行研究的调查人员提供行政援助和专业知识 我们丰富的生物资料库和来自PCPT和SELECT的临床数据库。

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.