Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Disease in Ukraine Following the Chernobyl Accident
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Purpose
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.
| Condition |
|---|
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Thyroid Cancer Thyroid Disease |
| Study Type: | Observational |
| Official Title: | Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Diseases in Ukraine Following the Chernobyl Accident |
| Estimated Enrollment: | 70000 |
| Study Start Date: | May 1995 |
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 Ukrainian children aged less than 18 years or in utero at the time of the accident were identified and have been examined by well-trained specialists. The main cohort was screened for thyroid disease every two years for 4 cycles ending in April, 2007. The in utero cohort was screened once, between 2003-2006. The study is a collaborative effort of researchers in Ukraine and the United States.
The main cohort includes approximately 13,000 persons who were children in 1986, all or most 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 will also be collected. All subjects are followed for thyroid cancer morbidity and mortality. Thyroid cancers are confirmed by expert pathology examination of tissue obtained during surgery. The in utero cohort includes a total of 2,582 individuals. In addition starting in 2003, ~ 7,000 parents of members of the main cohort who were under age 10 y at the time of the accident were interviewed in order to increase the accuracy of recall. These individuals were listed as new subjects. Altogether, 23,143 individuals have been accrued in this study.
In addition to the analysis of thyroid radiation measurements made in May-June, 1986, radiation dose to the thyroid was estimated drawing on such data as 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. For in utero subjects, fetal dose was estimated based on the mother's thyroid dose.
The aim of the study is to assess the early and late morphologic and functional changes in the thyroid glands of persons exposed at young ages to radiation from radioactive materials released as a consequence of the Chornobyl nuclear power plant accident, with emphasis on dose-and time-specific changes. 110 cancers were identified in the main cohort, and 8 confirmed or suspect cases were diagnosed among those exposed in utero. Active thyroid screening ended in April, 2007, but data analyses are being actively pursued.
There have been three scientific amendments to the protocol: transition cancer case ascertainment to a passive form of follow-up based on linkage to the National Cancer Registry of Ukraine (NCRU); a sub-study involving an additional follow-up examination of those cohort members who were diagnosed with benign nodular thyroid pathology during one of the earlier four active screening cycles; and genetic studies (gene expression and germline SNP studies) of thyroid cancer in this Ukrainian cohort exposed to radioiodines from Chornobyl fallout as children or adolescents. Work is continuing to complete the linkage follow-up, nodule follow-up and blood sample collection.
Eligibility| Ages Eligible for Study: | up to 34 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
Sample selection in Belarus consists of all children who were born between 26 April 1968 and 26 April 1986 and had their thyroid radio-activity measured in 1986 shortly after the accident.
Sample selection in Ukraine consists of all children who were born between 26 April 1968 and 26 April 1986 and had their thyroid radio-activity measured in 1986 shortly after the accident.
Sample from Ukraine lived at least part of the time between 26 April and 30 June 1986 in the town of Pripyat or in one of the 8 most contaminated raions (Ivankivskyi, Chornobylskyi, and Poliskyi raiions in the Kyiv Oblast; Narodychskyi and Ovruchskyi in Zhitomyr Oblast; Repkinsky. Kozeletskyi, and Chernihivskyi in Chernihiv Oblast).
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More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00341094 History of Changes |
| Obsolete Identifiers: | NCT00558610, NCT01338259 |
| Other Study ID Numbers: | 999995020, OH95-C-N020 |
| Study First Received: | June 19, 2006 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Cohort Radiation Thyroid Ukraine |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Thyroid Diseases Endocrine Gland Neoplasms Neoplasms by Site |
Neoplasms Head and Neck Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013