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Sponsor study identifier
Secondary identifiers
observational
19,456
1 country
2
Study Start
March 21, 1994
Actual (reported)Primary Completion
March 11, 2020
Actual (reported)Study Completion
March 11, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 11, 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.
March 21, 1994
Actual (reported)June 19, 2006
Actual (reported)June 21, 2006
Actual (reported)March 11, 2020
Actual (reported)March 11, 2020
Actual (reported)Radiation-related risk of benign and malignant thyroid disease
radiation risk estimate
2-3 years after initiation of study
subjects exposed to I131 in utero
subjects exposed to I131 at age less than 18 year
Subjects exposed to I131 at age less than 18 years, and subjects exposed to I131 in utero
Republican Resear ch Center for Radiation Medicine and Human Ecology
Homyel, Belarus
Ministry of Health Republic of Belarus
Minsk, Belarus
Drozdovitch V, Minenko V, Golovanov I, Khrutchinsky A, Kukhta T, Kutsen S, Luckyanov N, Ostroumova E, Trofimik S, Voilleque P, Simon SL, Bouville A. Thyroid Dose Estimates for a Cohort of Belarusian Children Exposed to (131)I from the Chernobyl Accident: Assessment of Uncertainties. Radiat Res. 2015 Aug;184(2):203-18. doi: 10.1667/rr13791.1. Epub 2015 Jul 24.
Zablotska LB, Nadyrov EA, Polyanskaya ON, McConnell RJ, O'Kane P, Lubin J, Hatch M, Little MP, Brenner AV, Veyalkin IV, Yauseyenka VV, Bouville A, Drozdovitch VV, Minenko VF, Demidchik YE, Mabuchi K, Rozhko AV. Risk of thyroid follicular adenoma among children and adolescents in Belarus exposed to iodine-131 after the Chornobyl accident. Am J Epidemiol. 2015 Nov 1;182(9):781-90. doi: 10.1093/aje/kwv127. Epub 2015 Oct 5.
Kiyohiko Mabuchi, M.D.
National Cancer Institute (NCI)
19,456 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
March 21, 1994
Actual (reported)Contact the study team to confirm eligibility.
Little MP, Kwon D, Zablotska LB, Brenner AV, Cahoon EK, Rozhko AV, Polyanskaya ON, Minenko VF, Golovanov I, Bouville A, Drozdovitch V. Impact of Uncertainties in Exposure Assessment on Thyroid Cancer Risk among Persons in Belarus Exposed as Children or Adolescents Due to the Chernobyl Accident. PLoS One. 2015 Oct 14;10(10):e0139826. doi: 10.1371/journal.pone.0139826. eCollection 2015.
Primary Completion
March 11, 2020
Actual (reported)Study Completion
March 11, 2020
Actual (reported)Last Updated
March 16, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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