CARET--THE BALTIMORE STUDY CENTER

CARET是一项正在进行的双盲肺癌化学预防试验， 30毫克β-胡萝卜素和25，000毫克β-胡萝卜素的组合的有效性和安全性 在两个高危人群中每日给予棕榈酸视黄酯IU：（a）男性和 主要从保险公司招募的女性现吸烟者和前吸烟者 来源，和（B）男性与广泛的职业石棉暴露 主要从就业来源招聘。我们记录 成功招募，良好的依从性，最小的副作用， 到目前为止，超过15，000名参与者在六个研究中心进行了随机化。通过 1993年4月30日，CARET随机抽取了4，000名接触石棉的工人， 超过所有五个CARD石棉中心的应计目标，以及11，105 烟瘾很大。西雅图和波特兰的吸烟人数已经超过了他们的重度吸烟者 目标，欧文是在轨道上实现其目标在1994年7月。期间 在最后五年期间，CARET将专注于保留，遵守 协议，确定端点，监控关键设计参数， 试验结束、分析和发表。预测表明 有14,240名吸烟者和4,010名石棉接触者， 到1998年2月，对114，100人-年的随访， 能够检测到两个国家肺癌发病率降低23%， 高风险人群合并，分别减少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 马里兰州大学职业健康项目获得资金， 1988年10月，作为CARET一部分，发起了一个巴尔的摩研究中心。 招募和随机化808名石棉暴露参与者， 1992年2月完成;最多20名参加者配偶， 符合重度吸烟者标准的学生在第5年被招募。期间 在最后五年期间，巴尔的摩研究中心将保持 目前研究维生素依从性和积极参与率很高。 工作人员将侧重于保留、查明和确认 主要和次要终点。研究结束的具体准备 分析数据和传播结果的工作将在 最近两年

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 CARD 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 University of Maryland Occupational Health Project received funding to initiate a Baltimore Study Center as part of CARET in October 1988. Recruitment and randomization of 808 asbestos-exposed participants was completed in February 1992; up to 20 participant spouses who themselves meet the criteria for heavy smokers are being recruited in year 5. During the final five year period the Baltimore Study Center will maintain the current high rates of study vitamin adherence and active participation. Staff will focus on retention and ascertainment and confirmation of primary and secondary endpoints. Specific preparations for study closeout and for analysis of data and dissemination of results will occur during the last two years.