PCPT and SELECT cohorts: Core Infrastructure Support for Cancer Research

描述(由申请人提供)：西雅图SWOG统计中心是两项大型前列腺癌预防试验的协调中心，即硒和维生素E癌症预防试验(SELECT)和前列腺癌预防试验(PCPT)。SELECT是一项第三阶段、双盲、安慰剂对照研究，旨在评估硒和维生素E单独和联合使用对前列腺癌发病率的影响。选择2001-2004年间随机选择的35,533名男性。PCPT也是一项第三阶段的双盲试验，在1994-1997年间随机选择了18,882名男性服用非那雄胺或安慰剂。尽管两者的时间表和要求不同，但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信息库。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、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。尽管到目前为止已经有了重大的科学合作，但仍有许多机会进一步询问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，并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继续积极关注可以联系到的一小部分男性，以获得更多数据。我们要求提供资金以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)，并支持这两个试验的持续数据分析应用程序。我们将继续努力获取前列腺组织 从被诊断患有前列腺癌的男性中选择，我们将从国家死亡指数搜索中获得死因信息。通过继续资助统计中心团队和我们的一些关键科学同事，我们能够帮助研究人员申请额外的资金，以使用我们来自PCPT和SELECT的丰富的生物库和临床数据库进行研究。 相关性：通过充分利用这些大型队列的数据和生物样本并进行广泛的随访，我们将能够评估前列腺癌的危险因素和随后的预后。我们将能够为研究人员提供临床和人口学数据以及被诊断为其他癌症的男性的生物样本，以更好地了解这些癌症的病因。

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.