CARET--STUDY 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25,000 mgβ-胡萝卜素联合使用的疗效和安全性 每天在两个高危人群中使用维甲酸棕榈酸酯：(A)男性和 女性现任和前任吸烟者主要是从保险公司招募的 来源，以及(B)有大量职业石棉接触的男性 主要从基于就业的来源招聘。我们已经记录了 成功招募，出色的合规性，并将副作用降至最低 到目前为止，超过15,000名参与者在六个研究中心随机进行了调查。穿过 1993年4月30日，Caret随机选择了4000名接触石棉的工人， 超过所有五个Caret石棉中心的应计目标，以及11,105 烟瘾很大的人。西雅图和波特兰已经超过了他们的重度吸烟者 欧文正在按部就班地在1994年7月实现其目标。在.期间 在最后五年期间，Caret将专注于保留、遵守 协议、端点的确定、关键设计参数的监控、 试验的收尾、分析和发表。预测表明 有14,240名吸烟者和4,010名接触石棉的参与者以及 114,100人年的跟踪调查，截至1998年2月，Caret将 能够检测到这两个国家的肺癌发病率降低了23% 高危人群加在一起，减少了27%、49%、32%和35% 吸烟者、女性吸烟者、男性吸烟者和接触石棉的亚组， 分别进行了分析。 波特兰研究中心将与4200人开展后续活动 参与者被随机分为重度吸烟者队列，280名参与者 随机进入石棉暴露工人队列，32名先锋 转接参与者。高依存性和完好性 确定终端和其他数据将是主要目标。临床上， 数据管理，后续活动包括年度和半年 门诊；常规电话问诊；症状、依从性、辅助性 变量和研究终点文件和报告；质量 数据收集的保证；以及根据既定的 CARET协议和程序。调查人员将与 协调中心和其他研究中心对分析和 数据的发布。

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 15,000 participants randomized thus far at six study centers. Through 30 April, 1993, CARET has randomized 4,000 asbestos-exposed workers, exceeding accrual goals at all five CARET asbestos centers, and 11,105 heavy smokers. Seattle and Portland have exceeded their heavy smoker goals, and Irvine is on track to achieve its goal in July 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 4,010 asbestos-exposed participants and 114,100 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%, 32%, and 35% reductions in the smokers, female smokers, male smokers, and asbestos-exposed subgroups, respectively. The Portland Study Center will conduct follow-up activities with 4,200 participants randomized into the heavy smoker cohort, 280 participants randomized into the asbestos-exposed worker cohort, and 32 Vanguard transfer participants. High adherence and retention and complete ascertainment of endpoints and other data will be primary goals. Clinical, data management, and follow-up activities include annual and semiannual clinic visits; routine telephone interviews; symptom, adherence, ancillary variables, and study endpoint documentation and reporting; quality assurance of data collection; and other tasks according to the established CARET protocol and procedures. The investigators will collaborate with the Coordinating Center and other Study Centers on the analyses and publication of data.