Radiation Exposure and Thyroid Disease in Kazakhstan
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00480428|
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : July 12, 2018
|First Submitted Date||May 30, 2007|
|First Posted Date||May 31, 2007|
|Last Update Posted Date||July 12, 2018|
|Study Start Date||May 17, 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Thyroid nodules [ Time Frame: 1998 ]|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00480428 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Radiation Exposure and Thyroid Disease in Kazakhstan|
|Official Title||Study to Improve Thyroid Doses From Fallout Exposure in Kazakhstan|
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.
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).
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.
In focus group format, participants are interviewed to collect information on the following at the time of nuclear tests:
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 Design||Time Perspective: Retrospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Enrollment||Not Provided|
|Study Completion Date||August 17, 2017|
|Primary Completion Date||Not Provided|
|Ages||65 Years to 90 Years (Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Kazakhstan|
|Removed Location Countries|
|Other Study ID Numbers||999907151
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )|
|Study Sponsor||National Cancer Institute (NCI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 17, 2017|