CHEMOPREVENTION EFFICACY TRIAL OF BETA CAROTENE/RETINOL

胡萝卜素和视黄醇疗效试验(CARET)为IV期 一项化学预防研究，旨在测试联合应用 视黄醇和β-胡萝卜素预防肺癌的两个高危人群 人口(A)从保险来源招募的重度吸烟者，以及 (B)职业性接触石棉严重的现任和前任工人 从工人补偿和基于就业的来源招聘。这个 双盲双臂随机方案将安慰剂与每日 30毫克β-胡萝卜素和25,000国际单位视黄醇的组合。当前 假设和预测表明，全面的疗效试验 将能够检测到肺癌的显著减少 两个高危人群的发病率加在一起，并在 两个小组中的任何一个单独。已经有足够数量的研究地点 确定了4000名石棉暴露受试者的应计项目。再来一次 主要站点INS按计划在1988年需要，以实现预期的 招募吸烟者(总数为13,000-14,000人)。 加州大学欧文分校(UCI)参与Caret Will 专注于从订阅名单中招募重度吸烟者 Kaiser Permanente、蓝十字和FHP，选定县的健康计划 在南加州(奥兰治、河滨、圣贝纳迪诺)。在.期间 UCI参与的头三年(1991-1994)，我们建议 招募、登记和跟踪4300名受试者根据 CARET协议的规范。UCI站点-有人口 招募额外参与者的基数应低于应计利润 其他研究地点的预测。我们将提供所有必要的数据 评估招聘、应计、 协调和成本，以产生对剩余部分的最佳估计 需要全面招生和后续跟进。

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.