PHASE IV CHEMOPREVENTION TRIAL BETA-CAROTENE/RETINOL

这项化学预防试验测试了视黄醇和 β-胡萝卜素在两个相关高危人群中预防肺癌的作用 人口：(A)从保险公司招募的重度吸烟者 来源，以及(B)现任和前任工人 从工人招募的职业石棉暴露量 薪酬和以就业为基础的来源。双盲，两个- ARM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。我们 会招募合资格的石棉暴露者 巴尔的摩地区。我们将参与实施成本- 有效的、整合良好的多诊所战略，具有 总部位于西雅图的项目管理和数据协调中心 分析。在新授权期的头两年(1988- 我们将随机招募800名受试者 根据多中心协议进行数据传输。我们将提供所有 评估应计、协调和成本所需的数据 地理上分散的诊所地点，以生成最佳估计 全面招生和后续招生的剩余需求- 向上。目前的假设和预测表明，完全- 规模疗效试验将能够检测到显著的 高危人群中肺癌发病率的降低 加在一起，仅在这两个小组中，就有13,000名吸烟者和 4000名接触石棉的受试者。

This chemoprevention trial tests the efficacy of retinol and beta-carotene in preventing lung cancer in two related 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 placebos with a daily combination of 30 mg beta-carotene plus 25,000 IU retinol. We will recruit eligible asbestos-exposed subjects from the Baltimore area. We will participate in implementing a cost- effective, well-integrated, multi-clinic strategy, with the Seattle-based coordinating center for project management and data analysis. During the first 2 years of the new grant period (1988- 91) we will recruit and enroll 800 subjects randomized according to the multi-center protocol. We will provide all necessary data to evaluate accrual, coordination, and costs in geographically-dispersed clinic sites to generate best estimates of the remaining needs for the full-scale enrollment and follow- up. Current assumptions and projections indicate that the full- scale Efficacy Trial will be capable of detecting significant reductions in lung cancer incidence in the high-risk groups combined, and in either subgroup alone, with 13,000 smokers and 4000 asbestos-exposed subjects.