CARET--COORDINATING CENTER

CARET是一项正在进行的肺癌化学预防双盲试验 30 mgβ-胡萝卜素与阿司匹林联合应用的疗效和安全性 在两个高危人群中每天使用25000国际单位的维甲酸棕榈酸酯：(A) 男性和女性现任和前任吸烟者主要从 基于保险的来源，以及(B)具有广泛职业的男性 主要从以就业为基础的来源招募石棉暴露。 我们记录了成功的招聘，出色的合规性，以及 到目前为止随机调查的18,000多名参与者的副作用最小 在六个研究中心。到1994年6月30日，Caret已经随机 4060名接触石棉的工人，全部五名超额完成应计目标 卡雷特石棉中心和14,057名重度吸烟者(44%是妇女)。其中两个 三个吸烟者中心超过了他们的目标，第三个中心将得出结论 1994年秋季的随机化。在最后五年期间，Caret 将重点放在保留、遵守协议、确定 终端，关键设计参数的监控，试验的收尾， 以及分析和出版。预测表明，有14,240人 吸烟者和4,060名接触石棉的参与者和114,400人- 经过多年的跟踪调查，到1998年2月，卡雷特将能够 检测到在这两个高风险地区肺癌发病率降低了23% 风险人群加在一起，减少了27%、49%、31%和35% 吸烟者、女性吸烟者、男性吸烟者和接触石棉的人 分别为子组。 协调中心继续负责所有 统计工作，与学习中心的密切联系，数据管理 和数据操作、进度报告、采购和质量控制 维生素的分配，血清和DNA银行，中心实验室， 审查和裁决终端数据、出版物和 演示文稿和一般管理。卡雷特是高度 补充ATBC(α-生育酚，β-胡萝卜素)的研究 芬兰29,000名男性吸烟者和哈佛医生健康研究 (仅有β-胡萝卜素)NCI投资组合中的22,000名男性 癌症化学预防试验。

CARET is an ongoing double-blind lung cancer chemoprevention trial of the efficacy and safety of the combination of 30 mg beta-carotene and 25,000 IU retinyl palmitate daily in two high-risk populations: (a) male and female current and former smokers recruited primarily from insurance-based sources, and (b) males with extensive occupational asbestos exposure recruited primarily from employment-based sources. We have documented successful recruitment, excellent compliance, and minimal side effects in over 18,000 participants randomized thus far at six study centers. Through 30 June, 1994, CARET has randomized 4,060 asbestos-exposed workers, exceeding accrual goals at all five CARET asbestos centers, and 14,057 heavy smokers (44% women). Two of the three smoker centers exceeded their goals, the third will conclude randomizations in fall 1994. During the final five-year period, CARET will focus on retention, adherence to protocol, ascertainment of endpoints, monitoring of key design parameters, closeout of the trial, and analysis and publication. Projections indicate that with 14,240 smokers and 4,060 asbestos-exposed participants and 114,400 person- years of follow-up through February 1998, CARET will be capable of detecting a 23% reduction in lung cancer incidence in the two high- risk populations combined, and 27%, 49%, 31%, and 35% reductions in the smokers, female smokers, male smokers, and asbestos-exposed subgroups, respectively. The Coordinating Center continues to be responsible for all statistical work, close liaison with study centers, data management and data operations, progress reports, purchase and quality-controlled distribution of vitamins, serum and DNA bank, central laboratory, review and adjudication of endpoints data, publications and presentations, and general administration. CARET is highly complementary to the ATBC (alpha-tocopherol, beta-carotene) study of 29,000 male smokers in Finland and the Harvard Physicians Health Study (beta-carotene alone) of 22,000 men in the NCI portfolio of major cancer chemoprevention trials.