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: 9339971
• 负责人: IAN M. THOMPSON
• 金额: $ 90.86万
• 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 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9339971
• 关键词: Adverse event; Ancillary Study; Basic Science; Biocompatible Materials; Biological; Biological Assay; Blood; Cancer Prevention Trial; Cardiovascular system; Cause of Death; Cessation of life; Clinical; Clinical Research; Clinical Trials; Collaborations; Collection; Colorado; Communities; Data; Data Analyses; Data Collection; Databases; Determination of Death; Diagnosis; Diet; Disease; Documentation; Double-Blind Method; Double-blind trial; Early Diagnosis; Epidemiology; Equipment and supply inventories; Etiology; Finasteride; Funding; Funding Agency; Genotype; Goals; Incidence; Institution; Laboratories; Leukocytes; Maintenance; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Newly Diagnosed; Outcome; Pathologic; Pharmaceutical Preparations; Phase; Physical activity; Placebos; Plasma; Postdoctoral Fellow; Prevention; Prevention trial; Primary Prevention; Procedures; Prostate; Prostate Cancer Prevention Trial; Quality of life; Randomized; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Risk Factors; Sampling; Schedule; Selenium; Selenium and Vitamin E Efficacy Trial; Serum; Source; Southwest Oncology Group; Specimen; Technical Expertise; Tissues; Universities; Vitamin E; anticancer research; base; biobank; cancer diagnosis; cancer prevention; cancer therapy; cohort; epidemiology study; follow-up; indexing; male health; men; outcome forecast; placebo controlled study; programs; prospective; randomized trial; repository; secondary analysis; statistical center

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.

描述（由申请人提供）：位于西雅图的SWOG统计中心担任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。SELECT在2001-2004年间随机分配了35，533名男性。PCPT也是一项III期双盲试验，在1994年至1997年期间将18，882名男性随机分配至非那肽或安慰剂组。虽然两者的时间表和要求不同，但在两者上收集了大量血清、血浆、白色血细胞和前列腺组织，从而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。尽管迄今为止已经有了重要的科学合作，但仍有许多机会进一步询问临床数据库和生物库。此外，已经获得了许多血清和血浆测量和基因分型数据，可供其他研究者使用。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以获取更多数据的男性子集。我们申请资金以提供稳定的基础设施，支持PCPT的血清库和PCPT和SELECT的组织库（均位于科罗拉多大学），并支持两项试验的持续数据分析应用。我们会继续努力获取前列腺组织 从被诊断为前列腺癌的男性中，我们将从国家死亡指数搜索中获得死亡原因信息。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，使用我们丰富的生物储存库和来自PCPT和SELECT的临床数据库进行研究。 相关性：通过充分利用这些大队列的数据和生物样本进行广泛的随访，我们将能够评估前列腺癌的风险因素和随后的预后。我们将能够为研究人员提供诊断患有其他癌症的男性的临床和人口统计学数据以及生物样本，以更好地了解这些癌症的病因。