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临床试验/NCT01265381
NCT01265381终止不适用

Thyroid Cancer Among Chornobyl Clean-up Workers in Ukraine: Pilot Study

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 673 人开始时间: 2010年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
673
试验地点
1
主要终点
To assess the radiation - related risk of thyroid cancer among the 150,000 male clean-up workers in Ukraine

研究概览

简要总结

Background:

  • The Ukrainian Research Center for Radiation Medicine and the U.S. National Institutes of Health have been studying cancer risks and outcomes in individuals who participated in the decontamination clean-up process following the Chornobyl nuclear accident. Some of these individuals were exposed to external radiation at various levels, as well as radioactive iodine that may have affected the thyroid and increased the risk of developing thyroid cancer. Because more individual and comparative data are needed on the affected populations and clean-up workers associated with the Chornobyl accident, researchers are interested in collecting personal information and saliva samples from Chornobyl clean-up workers who have been diagnosed with thyroid cancer.

Objectives:

  • To assess the radiation-related risk of thyroid cancer among male Chornobyl clean-up workers and collect saliva samples for an initial study.

Eligibility:

  • Male Chornobyl clean-up workers from Kyiv and Donetsk oblasts who have been diagnosed with thyroid cancer.

Design:

  • Participants will complete a standardized questionnaire during a personal interview. The questionnaire will ask for detailed information on the following areas of study:
  • Work history, conditions, and activities inside the 70-km clean-up and radiation calculation zone.
  • Residence history inside and outside the 30-km exclusion zone.
  • Milk consumption between April 26 and June 30, 1986 (to assess radioactivity from radioiodine fallout).
  • Potential non-radiation risk factors for thyroid cancer (e.g., smoking, alcohol consumption, family cancer history).
  • Participants will provide a saliva sample for pilot study testing....

详细描述

Background:

Much is known about the radiation-related risk of thyroid cancer, but there is considerable uncertainty about the magnitude of the radiation risk among those who were exposed as adults, particularly in males. A large number of clean-up workers, mostly male, who participated in decontamination and clean-up activities after the Chornobyl accident were exposed to external radiation at various levels. An increased thyroid cancer risk has been reported from studies of Russian, Estonian and Latvian clean-up workers, but there is little evidence of a dose response. However, recent published data from an IARC study of thyroid cancer cases and controls pooled from the Chornobyl clean-up workers in Belarus, Russia and Baltic countries show a strong dose response with an estimated risk per unit dose that is much higher than those reported from other irradiated populations exposed as adults. Following the completion of our NCI study of leukemia among Ukrainian clean-up workers, we are proposing a nested case-control study to assess the radiation-related risk of thyroid cancer among the 150,000 male cleanup workers in Ukraine. In preparation for this study, a pilot study is in progress to assess the feasibility of a full study.

Objectives:

The objectives are (i) to identify thyroid cancer cases and demographically matched controls without thyroid cancer occurring among the 150,000 Ukrainian clean-up workers through linkage to the National Cancer Registry and Chernobyl State Registry of Ukraine; (ii) to trace/locate and interview a small sample of subjects with thyroid cancer and their respective controls ; (iii) to obtain saliva buccal cell samples; and (iv) to locate and transfer thyroid tumor specimens from identified cases to the archive maintained at the Research Center for Radiation Medicine (RCRM),for diagnostic verification and possible future genetic/molecular research using the latest available techniques.

Eligibility:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To assess the radiation - related risk of thyroid cancer among the 150,000 male clean-up workers in Ukraine

时间窗: At time of analysis completion

Risk of thyroid cancer attributable to radiation

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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