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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 30, 2007 |
| Last Updated Date | August 24, 2009 |
| Start Date ICMJE | May 2007 |
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00480428 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Radiation Exposure and Thyroid Disease in Kazakhstan |
| Official Title ICMJE | Study to Improve Thyroid Doses From Fallout Exposure in Kazakhstan |
| Brief Summary | Residents of certain villages in Kazakhstan were exposed during childhood to radioactive fallout from nuclear tests conducted at the Semipalatinsk Nuclear Test Site (SNTS) between 1949 and 1962. Radiation doses to the thyroid from external and internal (i.e., ingested) radiation sources deposited as fallout are of interest because they may be jointly and differentially associated with increased risk of thyroid disease in this population. Objectives: To collect information about factors influencing radiation dose to the thyroid gland in children of two ethnic groups who were exposed to radioactive fallout from nuclear tests at the SNTS between 1949 and 1962. The two groups are Kazakhs (historically nomadic herders) and Europeans (typically descendants of Russian and German farmers). Eligibility: Women 70 years of age and older who had children or provided care to children during the 1950s. Men age 70 and older who were engaged in farming and care of dairy animals at the time of the nuclear tests. Design: In focus group format, participants are interviewed to collect information on the following at the time of nuclear tests:
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| Detailed Description | The proposed work will improve our understanding of historical, fallout-related radiation doses received by residents of villages in Kazakhstan immediately downwind from the Semipalatinsk Nuclear Test Site (SNTS), where multiple nuclear test explosions were carried out between 1949 and 1962. In collaboration with scientists at the Institute for Biophysics in Moscow, NCI has developed a combined bi-national dose reconstruction methodology based on lessons learned from studying radioactive fallout from tests at the SNTS in Kazakhstan, the Nevada Test Site in the United States, and other test sites. Gamma rays from radionuclides such as cesium 137 in fallout are highly penetrating and can affect all organs even when the radioactive source is outside the body, whereas less-penetrating beta particles from iodine 131, also plentiful in fallout, mainly affect the thyroid gland when ingested in milk from dairy animals grazing on contaminated pasture. We are particularly interested in both kinds of radiation doses to children, because their thyroid glands are small and very active, tend to concentrate ingested iodine, and are highly sensitive to radiation carcinogenesis. The conditions of fallout exposure in Kazakhstan are directly relevant to those following a hypothetical nuclear accident or radiation terrorism incident involving high levels of local fallout. We propose a field study in Kazakhstan to investigate aspects of typical daily village life in areas affected by fallout that might influence individual radiation doses to the thyroid gland. Using focus group interviews, we will collect retrospective information about factors influencing radiation dose to the thyroid gland in children of two distinct ethnic groups (Kazakh and European). These factors include milk and milk product consumption, dependence on different species of dairy animals known to differ with respect to concentration of iodine in milk, seasonal practices of pasturing and supplemental feeding of dairy animals at the time of the nuclear tests, time children typically spent outdoors, and radiation shielding provided by dwellings and other buildings. We will also ask about protective measures taken at the time, such as details of temporary evacuations of villages predicted to be in the fallout paths from particular tests. These data will fill key gaps in the current dose-reconstruction methodology and should result in improved dose estimates, as well as a basis for evaluating and quantifying dosimetric uncertainty and related biases in risk estimates. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Retrospective |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 128 |
| Completion Date | |
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE |
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| Gender | Both |
| Ages | 65 Years to 90 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Kazakhstan |
| Administrative Information | |
| NCT ID ICMJE | NCT00480428 |
| Responsible Party | |
| Study ID Numbers ICMJE | 999907151, 07-C-N151 |
| Study Sponsor ICMJE | National Cancer Institute (NCI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | December 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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