Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study

α-生育酚、β-胡萝卜素癌症预防 (ATBC) 研究

• 批准号: 10263763
• 负责人: Demetrius Albanes
• 金额: $ 43.64万
• 依托单位: DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10263763
• 关键词: Age; All-Trans-Retinol; Beta Carotene; Biological Markers; Carotene; Caucasians; Cessation of life; Chest; Cigarette; Cohort Analysis; Collaborations; Data; Diet; Dietary Questionnaires; Erythrocytes; Film; Finland; Follow-Up Studies; Food; Freezing; Genetic; Genome Scan; Genotype; Goals; Habits; Health; High Density Lipoprotein Cholesterol; Human; Institutes; International; Intervention; Investigation; Lung; Malignant Neoplasms; Measurement; Medical; Medical Records; Metabolic; National Cancer Institute; Nested Case-Control Study; Nutritional; Occupational; Participant; Pathology; Phase; Phenotype; Placebos; Public Health; Randomized; Randomized Controlled Trials; Sampling; Serum; Smoker; Smoking; Structure of nail of toe; Supplementation; Surveys; Thoracic Radiography; Visit; Vitamin E; Vitamin E Acetate; Whole Blood; alpha Tocopherol; base; cancer prevention; capsule; cohort; design; effectiveness testing; epidemiology study; follow-up; group intervention; male; men; metabolomics; neoplasm registry; population based; prevent; recruit; side effect

The ATBC Cohort Follow-up Study has been in place since 1994. Male smokers between the ages of 50 and 69 were recruited from southwestern Finland between April 1985 and June 1988. A total of 29,133 men were randomly assigned to one of four intervention groups: 50 mg/day alpha-tocopherol (as dl-alpha-tocopheryl acetate); 20 mg/day beta-carotene; both alpha-tocopherol and beta-carotene; or placebo. They were followed for five to eight years during the trial, until death, or 30 April 1993 when intervention was stopped (median follow-up, 6.1 years). Follow-up for endpoints was continued postintervention. Following invitation for participation and recruitment through a population-based postal survey, the trial randomly assigned 29,133 Caucasian 50-69 year old male smokers of 5 cigarettes daily to one of four intervention groups based on a 2x2 factorial design: beta-carotene (20 mg/day), vitamin E (50 mg/day, as dl-alpha-tocopheryl acetate), both agents, or placebo. At entry, medical, dietary, smoking, and occupational data were obtained, along with physical measurements, a chest x-ray, and serum and toenail samples. Diet was captured through a 276 food item dietary questionnaire that was developed and validated for the trial. Baseline serum was collected, frozen, and stored for all participants, and vitamin E, beta-carotene, retinol, and total and HDL cholesterol were determined. Follow-up serum and whole blood were collected for all active participants later in the study, as were additional serum and red blood cell samples from selected subsets. Active intervention continued for 5-8 years, with three study visits annually during which participants were asked about their health and possible subjective side effects, capsule compliance, and smoking habits since the last visit. Chest films were taken at 2-3 year intervals and at the end of the trial. All incident cancers were identified through the nationwide Finnish Cancer Registry, medical records/pathology sli

ATBC队列后续研究自1994年以来一直存在。年龄在50岁到69岁之间的男性吸烟者是在1985年4月至1988年6月期间从芬兰西南部招募的。共有29,133名男性被随机分配到四个干预组中的一个：50毫克/天的α-生育酚(如dl-α-生育酚醋酸酯)；20毫克/天的β-胡萝卜素；α-生育酚和β-胡萝卜素；或安慰剂。在试验期间，他们被跟踪了5至8年，直到死亡，或1993年4月30日停止干预(中位数随访，6.1年)。干预后继续对终点进行随访。在通过基于人群的邮寄调查邀请参与和招募之后，该试验基于2x2析因设计将29,133名50-69岁的高加索人男性吸烟者随机分配到四个干预组中的一个：β-胡萝卜素(20毫克/天)、维生素E(50毫克/天，如dl-α-生育酚醋酸酯)，这两种药物都是药物，或者是安慰剂。在进入时，获得了医疗、饮食、吸烟和职业数据，以及体格测量、胸部X光和血清和脚趾甲样本。饮食是通过276项食物饮食问卷获得的，该问卷是为试验开发和验证的。为所有参与者收集、冷冻和储存基线血清，并测定维生素E、β-胡萝卜素、视黄醇、总胆固醇和高密度脂蛋白。随后在研究中收集了所有活跃参与者的随访血清和全血，并从选定的亚组中收集了额外的血清和红细胞样本。积极干预持续了5-8年，每年进行三次研究访问，在此期间，参与者被问及他们的健康和可能的主观副作用、胶囊依从性和自上次访问以来的吸烟习惯。试验结束时，每隔2-3年拍摄一次胸片。所有发生的癌症都是通过芬兰全国癌症登记处、医疗记录/病理切片进行识别的