Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Disease in Belarus Following the Chernobyl Accident
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19,456
- 试验地点
- 2
- 主要终点
- Radiation-related risk of benign and malignant thyroid disease
研究概览
简要总结
Iodine-131(131I) and other radioisotopes of Iodine are contained in fallout from atmospheric nuclear weapons tests and are among the radionuclides most likely to be released in a nuclear reactor accident. In spite of nearly 50 years of experience, the risk of thyroid disease, especially thyroid cancer, attributable to exposure to 131I remains unknown, although the carcinogenic potential of x-ray and gamma-ray exposure of the thyroid is reasonably well known. The available data also indicate that children face greater risks of radiation-induced thyroid cancer than do adults.
The nuclear power plant accident at Chernobyl released large quantities of 131I and other radioisotopes of iodine into the atmosphere, contaminating thousands of square kilometers and exposing millions of people. It is proposed that a well-defined subset of Belarussian children aged 0-18 years at the time of the accident be examined by well-trained specialists for thyroid disease at least biennially for up to 30 years. A cohort of 15,000 children has been identified, all of whom had their thyroids measured for radioactivity during the weeks immediately following the accident. Under a rigid research protocol these children will receive complete diagnostic thyroid examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory tests, and fine-needle aspiration, as appropriate. Cancer will be determined by expert pathology examination of tissue. In addition to the analysis of thyroid radiation measurements made in May-June, 1986, efforts will be made to reconstruct each person's exposure and to estimate the radiation doses to the thyroid. This will involve the reconstruction of deposition patterns and environmental pathways of the radioiodines, and of the location, dietary characteristics, and lifestyle of each person throughout the exposure period.
The data will be analyzed to evaluate the relationship, if any, between thyroid disease, especially cancer, and the radiation dose to the thyroid, with emphasis on the dose from 131I. The primary focus will be on dose-response analyses of person-year incidence data with stratification by sex, age at exposure, geographic area, time, and age at risk. Confounding factors, e.g., use of potassium iodide (KI) as a prophylactic measure, will be evaluated and controlled in the analysis, and the uncertainty of the dose estimates will be taken into account.
In addition to producing risk coefficients for thyroid cancer and other thyroid diseases in children as a function of sex and age at the time of exposure, it is expected that the analyses will contribute new knowledge of the carcinogenic effectiveness of 131I in comparison with that of x-ray and gamma radiation. This information will fill a major gap in the world's knowledge of radiation effects, and will provide guidance for radiation protection and public health policies wherever nuclear reactors are in operation.
详细描述
The nuclear power plant accident at Chornobyl released large quantities of Iodine-131 and other radioisotopes of iodine into the atmosphere, contaminating thousands of square kilometers and exposing millions of people. For this study, a well-defined subset of Belarusian children under age 18 years at the time of the accident were identified and examined by well-trained specialists for thyroid disease every two years for three cycles. The study is a collaborative effort of researchers in Belarus and the United States.
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The cohort includes approximately 12,000 persons who were children in 1986, all of whom had their thyroids measured for radioactivity during the weeks immediately following the accident. Under a rigid research protocol these subjects received diagnostic thyroid examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory tests. If indicated, they were referred for a fine-needle aspiration biopsy. Interview information regarding residential, health, diet and lifestyle history are also collected. All subjects were followed for thyroid cancer morbidity and mortality. Overall, 163 cancers were identified. Interviews with mothers of the subjects who were less than 10 years of age at the time of the accident whose memory of events proved inadequate increased the total accrual to 13,552.
Based on thyroid radiation measurements made in May-June, 1986, and other information (reconstruction of deposition patterns and environmental pathways of the radioiodines, and of the location, dietary characteristics, and lifestyle of each person throughout the exposure period), each person s radiation dose to the thyroid was estimated.
The aim of the study is to assess the early and late morphologic and functional changes in the thyroid glands of young persons exposed to radiation from radioactive materials released as a consequence of the Chornobyl nuclear power plant accident, with emphasis on dose- and time-specific changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 51 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Radiation-related risk of benign and malignant thyroid disease
时间窗: 2-3 years after initiation of study
radiation risk estimate
次要结局
未报告次要终点
