Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339716
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2006-06-19
Brief Title:
Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Disease in Belarus Following the Chernobyl Accident
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Disease in Belarus Following the Chernobyl Accident
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Iodine-131131I 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 15000 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 persons 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 eg 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 worlds knowledge of radiation effects and will provide guidance for radiation protection and public health policies wherever nuclear reactors are in operation
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 15000 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 persons 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 eg 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 worlds knowledge of radiation effects and will provide guidance for radiation protection and public health policies wherever nuclear reactors are in operation
Detailed Description:
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 Belarusian children under age 18 years at the time of the accident were identified and examined by well-trained specialists for thyroid disease every two years for three cycles The study is a collaborative effort of researchers in Belarus and the United States
TAB
The cohort includes approximately 12000 persons who were children in 1986 all 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 are also collected All subjects were followed for thyroid cancer morbidity and mortality Overall 163 cancers were identified Interviews with mothers of the subjects who were less than 10 years of age at the time of the accident whose memory of events proved inadequate increased the total accrual to 13552
Based on thyroid radiation measurements made in May-June 1986 and other information 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 each person s radiation dose to the thyroid was estimated
The aim of the study is to assess the early and late morphologic and functional changes in the thyroid glands of young persons exposed to radiation from radioactive materials released as a consequence of the Chornobyl nuclear power plant accident with emphasis on dose- and time-specific changes
Active screening for thyroid cancers ended in September 2006 The third and final thyroid screening examinations were completed in September 2006 identifying 163 cases of thyroid cancer during the examination period Subject accrual through screening is no longer ongoing Thyroid and other cancer case ascertainment is underway by linkage to the Belarusian Cancer Registry A paper has been published on the radiation dose response for prevalent thyroid cancer and analyses of incident cancer cases and other thyroid disease are ongoing
TAB
The cohort includes approximately 12000 persons who were children in 1986 all 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 are also collected All subjects were followed for thyroid cancer morbidity and mortality Overall 163 cancers were identified Interviews with mothers of the subjects who were less than 10 years of age at the time of the accident whose memory of events proved inadequate increased the total accrual to 13552
Based on thyroid radiation measurements made in May-June 1986 and other information 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 each person s radiation dose to the thyroid was estimated
The aim of the study is to assess the early and late morphologic and functional changes in the thyroid glands of young persons exposed to radiation from radioactive materials released as a consequence of the Chornobyl nuclear power plant accident with emphasis on dose- and time-specific changes
Active screening for thyroid cancers ended in September 2006 The third and final thyroid screening examinations were completed in September 2006 identifying 163 cases of thyroid cancer during the examination period Subject accrual through screening is no longer ongoing Thyroid and other cancer case ascertainment is underway by linkage to the Belarusian Cancer Registry A paper has been published on the radiation dose response for prevalent thyroid cancer and analyses of incident cancer cases and other thyroid disease are ongoing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH95-C-N021 | None | None | None |