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18，314名肺癌高危人群中研究每日30 mg β-胡萝卜素和25，000 ID棕榈酸视黄酯联合用药的癌症预防疗效和安全性。该试验于1985年开始招募，并于1996年1月停止，比计划提前了21个月，得出了两个结论，即干预对肺癌发病率和总死亡率没有益处，并有大量证据表明干预对肺癌发病率和总死亡率有有害影响。参与者在干预后被随访了9年多，2004年发表了最新的肺癌发病率和心血管疾病死亡率结果。2005年6月30日，CARET停止了对参与者的积极随访。在CARET的主动干预阶段，收集了血清、血浆、全血和肺组织样本。这些生物样本组成了CARET生物储存库，这是该UML应用程序的焦点。CARET生物储存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，并已向任何研究者开放，并开展假设驱动的项目。到目前为止，我们已经向研究人员提供了来自储存库的生物标本，这导致了39篇同行评审的出版物。目前有29个项目正在进行中。在本申请中，我们要求资金继续支持CARET生物储存库和相关的广泛数据库，此外，我们将利用这一机会申请资金，以扩展CARET数据库，并提高我们的生物储存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生物储存库和数据库，以促进研究和合作，2）扩展CARET数据库和在线访问，包括参与者使用微量营养素，矿物质和维生素补充剂; 基线实验室值;以及肺癌、前列腺癌和结肠癌病例诊断时的分期。3)通过公共登记处搜索，扩展CARET对癌症、死亡和死亡原因的随访。

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.