PCPT and SELECT cohorts: Core Infrastructure Support for Cancer Research

描述（由申请人提供）：西雅图SWOG统计中心作为两个大型前列腺癌预防试验的协调中心，硒和维生素E癌症预防试验（SELECT）和前列腺癌预防试验（PCPT）。SELECT是一项三期、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。SELECT在2001-2004年间随机抽取35,533名男性。PCPT也是一项III期双盲试验，在1994-1997年期间，18,882名男性随机服用非那雄胺或安慰剂。虽然时间表和要求在两者之间有所不同，但两者都收集了大量的血清、血浆、白细胞和前列腺组织，从而产生了丰富的生物储存库。每个人都有广泛的前瞻性数据收集，包括饮食和补充剂、生活质量、身体活动、药物、其他癌症诊断、心血管终点和治疗不良事件。尽管迄今为止已经有了重大的科学合作，但仍有许多机会进一步审查临床数据库和生物库。此外，已经获得了一些血清和血浆测量以及基因分型数据，可供其他研究人员使用。现在临床试验部分已经完成，这些队列可以用于流行病学研究。此外，SELECT继续积极跟踪可以联系的男性子集以获取额外数据。我们要求资金提供稳定的基础设施，以支持PCPT的血清库和PCPT和SELECT的组织库（均位于科罗拉多大学），并支持两项试验正在进行的数据分析应用。我们将继续努力获得前列腺组织

DESCRIPTION (provided by applicant): The SWOG Statistical Center in Seattle 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, on prostate cancer incidence. SELECT randomized 35,533 men between 2001-2004. PCPT, also a Phase III, double-blind trial, randomized 18,882 men to either finasteride or placebo between 1994-1997. Although schedules and requirements varied between the two, 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 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, a number of serum and plasma measures and genotyping data have already been obtained and are available for other investigators to use. Now that the clinical trial portion is completed, these cohorts can be used for epidemiologic research. Also, SELECT continues to actively follow a subset of men who can be contacted for additional data. We request funds to provide a stable infrastructure to support the serum repository for PCPT and tissue repository for PCPT and SELECT (all located at the University of Colorado) and to support the ongoing data analysis applications from both trials. We will continue our efforts to obtain prostate tissue from men diagnosed with prostate cancer on SELECT, and we will obtain cause of death information from a National Death Index search. By continuing to fund the Statistical Center team and some of our key scientific colleagues, we are able to help investigators apply for additional funding to conduct studies using our rich biologic repositories and clinical databases from PCPT and SELECT. RELEVANCE: By fully using the data and biologic samples from these large cohorts with extensive follow-up, we will be able to evaluate risk factors for prostate cancer, and subsequent prognosis. We will be able to contribute clinical and demographic data and biologic samples for men diagnosed with other cancers to researchers to better understand the etiology of those cancers.