CARET--COORDINATING CENTER

CARET--协调中心

• 批准号: 2105672
• 负责人: GILBERT S OMENN
• 金额: $ 403.24万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-07-01 至 1999-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2105672
• 关键词: all trans retinol; asbestos; cancer prevention; cancer risk; carotene; chemoprevention; combination cancer therapy; computer data analysis; female; gender difference; human mortality; human subject; lung neoplasms; male; mesothelioma; neoplasm /cancer epidemiology; nutrition aspect of cancer; occupational hazard; statistical service /center; statistics /biometry; tobacco abuse

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.

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 IU棕榈酸视黄酯每日用于两个高危人群：（a） 男性和女性目前和以前的吸烟者主要从 基于保险的来源，以及（B）具有广泛职业的男性 石棉暴露主要来自就业来源。 我们记录了成功的招聘，出色的合规性， 迄今为止，超过18，000名随机化参与者的副作用最小 六个研究中心。 到1994年6月30日，CARET已随机 4 060名接触石棉的工人，超过了所有五个国家的应计目标 CARET石棉中心和14,057名重度吸烟者（44%为女性）。 两 三个吸烟者中心超过了他们的目标，第三个将得出结论， 1994年秋季随机化。在最后五年期间， 将侧重于保留、遵守方案、确定 终点、关键设计参数监测、试验结束， 分析和出版。预测显示， 吸烟者和4，060名石棉接触者以及114，400人- 到1998年2月，CARET将能够 检测到两个高- 风险人群合并，分别减少27%、49%、31%和35%， 吸烟者、女性吸烟者、男性吸烟者和石棉暴露者 子组，分别。 协调中心继续负责所有 统计工作、与研究中心的密切联系、数据管理 和数据操作，进度报告，采购和质量控制 分发维生素、血清和DNA库、中心实验室， 终点数据、出版物和 介绍和一般管理。关怀是高度 补充ATBC（α-生育酚，β-胡萝卜素）研究， 芬兰29，000名男性吸烟者和哈佛医师健康研究 （β-胡萝卜素单独）的22,000名男子在NCI投资组合的主要 癌症化学预防试验