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Sponsor study identifier
Secondary identifiers
observational
23,143
1 country
1
Study Start
May 1, 1995
Actual (reported)Primary Completion
October 8, 2020
Actual (reported)Study Completion
October 8, 2020
Actual (reported)The nuclear power plant accident at Chornobyl released large quantities of Iodine-131 and other radioisotopes of iodine in the atmosphere, contaminating thousands of square kilometers and exposing millions of people. For this study, a well-defined subset of Ukrainian children aged 0-18 years or in utero at the time of the accident are being identified and examined by well-trained specialists for thyroid disease every two years for at least three cycles. The study is a collaborative effort of research in Ukraine and the United States. The cohort will include approximately 13,000 persons who were children in 1986, all or most of whom have had their thyroids measured for radioactivity during the weeks immediately following the accident (or whose mothers had measurements taken while the child was in utero). Under a rigid research protocol these subjects will receive diagnostic thyroid examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory tests, and, if indicated, fine-needle aspiration biopsy. Interview information regarding residential, health, diet and lifestyle history will also be collected. All subjects will be followed for thyroid cancer morbidity and mortality. Thyroid cancers will be confirmed 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 dose 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 aim of the study is to carry out valid and credible assessments of the early and late morphologic and functional changes in the thyroid glands of persons exposed to radiation from radioactive materials released as a consequence of the Chornobyl nuclear power plant accident. The emphasis is on dose- and time-specific changes. In the course of the study other possible risk factors will be examined including dietary iodine intake during and after 1986, and the ingestion of potassium iodide for thyroid protection shortly after the accident.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 8, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 1995
Actual (reported)June 19, 2006
Actual (reported)June 21, 2006
Actual (reported)October 8, 2020
Actual (reported)October 8, 2020
Actual (reported)Radiation related risk of benign and malignant thyroid disease
Radiation risk
2-3 years after initiation of study
Subjects exposed to I131 before the age of 18 years
Subjects exposed to I131 in utero
Subjects exposed to I131 before the age of 18 years and subjects exposed to I131 in utero
Research Institute of Endocrinology and Metabolism, Kiev, Ukraine
Kiev, Ukraine
Elizabeth K Cahoon
National Cancer Institute (NCI)
23,143 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
May 1, 1995
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 8, 2020
Actual (reported)Study Completion
October 8, 2020
Actual (reported)Last Updated
October 9, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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