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

基本信息

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
项目类别：
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

项目摘要

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）：西雅图的 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 III 期、双盲、安慰剂对照研究，旨在评估单独或联合使用硒和维生素 E 对前列腺癌发病率的影响。 SELECT 在 2001 年至 2004 年间对 35,533 名男性进行了随机分组。 PCPT 也是一项 III 期双盲试验，在 1994 年至 1997 年间随机将 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，从而形成了丰富的生物样本库。每个研究都收集了广泛的前瞻性数据，其中包括饮食和补充剂、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。尽管迄今为止已经开展了重要的科学合作，但仍然存在许多进一步研究临床数据库和生物库的机会。此外，已经获得了许多血清和血浆测量值以及基因分型数据，可供其他研究人员使用。现在临床试验部分已经完成，这些队列可用于流行病学研究。此外，SELECT 继续积极追踪一部分可以联系以获取更多数据的男性。我们请求资金提供稳定的基础设施，以支持 PCPT 的血清存储库以及 PCPT 和 SELECT 的组织存储库（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。我们将继续努力获取前列腺组织来自 SELECT 上诊断患有前列腺癌的男性，我们将从国家死亡指数搜索中获取死因信息。通过继续资助统计中心团队和一些重要的科学同事，我们能够帮助研究人员申请额外的资金，以使用我们丰富的生物资源库以及来自 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以及随后的预后。我们将能够向研究人员提供被诊断患有其他癌症的男性的临床和人口统计数据以及生物样本，以更好地了解这些癌症的病因。