Clinical trial · Observational
Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Disease in Belarus Following the Chernobyl Accident
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Cancer Thyroid Disease | — | UNRESOLVED | — |
| Non Thyroid Cancer | — | UNRESOLVED | — |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Belarus in utero
- description
- subjects exposed to I131 in utero
- label
- Main BelAm
- description
- subjects exposed to I131 at age less than 18 year
Primary outcomes (1)
- measure
- Radiation-related risk of benign and malignant thyroid disease
- timeFrame
- 2-3 years after initiation of study
- description
- radiation risk estimate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 51 Years
Show eligibility criteria text
* INCLUSION CRITERIA: We will include about 3,000 individuals born in Belarus from April, 26, 1986 through March, 31, 1987 who were exposed to internal and external sources of ionizing radiation during prenatal and early postnatal periods due to the Chernobyl fallout. EXCLUSION CRITERIA: For the purpose of individual dose reconstruction we need to establish child-mother pair for each cohort member and conduct personal dosimetric interview with child s mother. We anticipate that some of the eligible subjects will be deceased at the time of the cohort construction. Deceased subjects will not be included in the cohort. Excluded from the interview study and the subsequent follow-up study will be those who are deceased, cannot be located, refuse to participate in the study, or do not provide informed consent.
References
Publications (3)
- BACKGROUNDDrozdovitch 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. PMID 26207684
- BACKGROUNDZablotska 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. PMID 26443421
- BACKGROUNDLittle 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. PMID 26465339