INFRASRUCTURE SUPPORT AND DATA ENHANCEMENTS FOR THE CARET BIOREPOSITORY

描述（由申请人提供）：胡萝卜素和视黄醇疗效试验（CARET）是一项随机、双盲、安慰剂对照试验，在18314名肺癌高危人群中，每日联合服用30mg（3-胡萝卜素）和25,000 ID视黄醇棕榈酸酯的防癌疗效和安全性。试验于1985年开始招募人员，并于1996年1月停止，比计划提前了21个月，得出了两项结论，即没有益处，并有大量证据表明干预措施对肺癌发病率和总死亡率都有有害影响。干预后对参与者进行了9年多的随访，并于2004年公布了最新的肺癌发病率和心血管疾病死亡率调查结果。2005年6月30日，CARET停止对参与者的积极随访。在CARET积极干预阶段，采集血清、血浆、全血和肺组织标本。这些生物样本组成了CARET生物存储库，这是这个UMl应用程序的重点。CARET生物库是研究疾病发展和进展的关键工具，是母试验的宝贵遗产，并向任何有假设驱动项目的研究者开放。迄今为止，我们已经向研究人员提供了生物标本，并发表了39篇同行评议的出版物。目前有29个活跃项目。在此申请中，我们请求资金继续支持CARET生物库和相关的广泛数据库，此外，我们将利用这个机会请求资金来扩展CARET数据库并改善我们的生物库对研究人员的可访问性。该应用程序的具体目标是：1)维护和支持CARET生物库和数据库，为研究做出贡献和合作；2)扩展CARET数据库和在线可访问性，包括参与者使用微量营养素、矿物质和维生素补充剂；

DESCRIPTION (provided by applicant): The Carotene and Retinol Efficacy Trial (CARET) was a randomized, double-blind, placebo-controlled trial of the cancer prevention efficacy and safety of a daily combination of 30 mg of (3-carotene and 25,000 ID of retinyl palmitate in 18,314 persons at high risk for lung cancer. The trial began recruitment in 1985 and was halted in January 1996, 21 months ahead of schedule, with the twin conclusions of no benefit and substantial evidence of a harmful effect of the intervention on both lung cancer incidence and total mortality. Participants were followed for over nine years post-intervention, with updated lung cancer incidence and cardiovascular disease mortality findings published in 2004. On June 30, 2005, CARET stopped active follow-up of participants. During the active intervention phase of CARET, serum, plasma, whole blood, and lung tissue specimens were collected. These biospecimens make up the CARET biorepository which is the focus of this UMl application. The CARET biorepository is a key tool in studying disease development and progression and is an invaluable legacy of the parent trial and has been open to any investigator with a hypothsis driven project. To date we have provided biospecimens from the repository to investigators which have resulted in 39 peer reviewed publications. Currently there are 29 active projects. In this application we request funds to continue support ofthe CARET biorepository and the associated extensive database, in addition, we will use this opportunity to request funds to extend the CARET database and improve the accessibility of our biorepository to investigators. The specific aims of this application are: 1) Maintain and support the CARET Biorepository and database to contribute to and collaborate in research, 2) Extend the CARET database and online accessibility to include participant use of micronutrient, mineral, and vitamin supplements; baseline laboratory values; and stage at diagnosis of lung, prostate, and colon cancer cases. 3) Extend CARET follow-up with cancers, deaths, and causes of death via public registry searches.