CHEMOPREVENTION EFFICACY TRIAL OF BETA-CAROTENE/RETINOL

胡萝卜素和视黄醇疗效试验（CARET）是一项IV期研究， 化学预防研究，该研究测试以下物质的组合的功效： 维生素A和β-胡萝卜素预防肺癌的两个高风险 （a）从保险来源招募的重度吸烟者， (B)职业性石棉暴露严重的在职和离职工人 从工人补偿和基于就业的来源招聘。 的 双盲两组随机方案比较安慰剂与每日 30毫克β-胡萝卜素加25，000 IU视黄醇的组合。 电流 假设和预测表明，全规模疗效试验 能够检测出肺癌的显著减少， 两个高风险组的发病率合并， 单独的亚组。 已经有足够数量的研究中心 确定了4000例石棉暴露受试者的累积。 一个附加 按1988年的计划，需要主要的现场信息系统，以实现预期的目标。 招募吸烟者（共13 000至14 000人） 加州尔湾大学（UCI）参与CARET将 集中从《吸烟条例》的登记册中招募大量吸烟者， Kaiser Permanente、Blue Cross和FHP，选定县的健康计划 在南加州（橙子，滨江，圣贝纳迪诺）。 期间 在UCI参与的头三年（1991-1994年），我们建议 招募、入组和随访4300例受试者， CARET协议的规范。 UCI网站-有人口 如果应计费用低于 其他研究中心的预测。 我们将提供所有必要的数据 评估招聘，应计， 对剩余的项目进行最佳估计的协调和费用 需要进行全面的入组和随访。

The Carotene and Retinol Efficacy Trial (CARET) is a Phase IV chemoprevention study which tests the efficacy of the combination of retinol and beta-carotene to prevent lung cancer in two high-risk populations (a) heavy smokers recruited from insurance-based sources, and (B) current and former workers with heavy occupational asbestos exposure recruited from workers' compensation and employment-based sources. The double-blind two-arm randomized protocol compares placebo to a daily combination of 30 mg beta-carotene plus 25,000 IU retinol. Current assumptions and projections indicate that the full scale Efficacy Trial will be capable of detecting significant reductions in lung cancer incidence in the two high-risk groups combined and larger reductions in either subgroup alone. An adequate number of study sites have been identified for accrual of 4000 asbestos-exposed subjects. One additional major site ins needed as planned in 1988, to achieve the desired recruitment of smokers (13,000 -14,000 total.) The participation of University of California, Irvine (UCI) in CARET will focus on the recruitment of heavy smokers from the subscribers lists of the Kaiser Permanente, Blue Cross and FHP, Health Plans for selected counties in Southern California (Orange, Riverside, San Bernardino). During the first three years of UCI's participation (1991-1994), we propose to recruit, enroll and follow 4300 subjects randomized according to the specifications of the CARET protocol. The UCI site -has the population base from which to recruit additional participants should accrual be below projections at the other study sites. We will provide all necessary data to evaluate recruitment, accrual, coordination and costs to generate the best estimates of the remaining needs for the full-scale enrollment and follow-up.