Thyroid Cancer Clinical Trial
Official title:
Studies of Thyroid Abnormalities in Northeastern Kazakhstan Associated With Nuclear Weapons Testing
Verified date | November 18, 2016 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
We propose to study the prevalence of thyroid nodules and cancer in relation to radiation
dose, in a defined cohort of Kazakhstan residents exposed as children to radioactive fallout
from atomic bomb tests at the neighboring Semipalatinsk Test Site (STS). The population near
the STS is believed to have received radiation doses from fallout that were much higher than
that experienced by any population of comparable size in the US. The study population is a
defined cohort of 20,000 residents, half of whom, in 1960, resided in heavily-exposed
villages; the other half lived in lightly-exposed villages. The population is rural, with a
diet that was and is heavily dependent upon fresh milk from household or local cows and
therefore likely to have led to ingestion of radioactive iodine from fallout. The study is
two parts.
The first part involves a cytogenetic assay for radiation biodosimetry purposes of peripheral
lymphocytes obtained from blood samples donated by 40 cohort members with individuals
radiation dose estimates. Blood samples will be collected from 25 putative high-dose and 15
low-dose cohort members and processed or cytogenetic assay using fluorescent in situ
hybridization (FISH) for stable chromosome aberrations in peripheral lymphocytes. This
biodosimetric validation assay, will be carried out by Nailya Chaizhunusova, chief of
cytogenetics at the Scientific research Institute for Radiation Medicine and Ecology, in
collaboration with Dr. Tracy Yang at the NASA Johnson Space Center in Houston, Texas. It
should be possible to detect gamma radiation doses as low as 150 mGy.
The second part will involve thyroid screening by ultrasound in selected villages. The
population to be screened will comprise 100-1500 members of the study cohort exposed as young
children to high fallout levels, and equal numbers of comparable ages exposed to little or no
fallout. Fine needle aspiration biopsy will be performed, under separate informed consent, if
the palpation and ultrasound results suggest presence of a tumor. Presence and malignancy of
tumor will be determined by cytopathology. Subjects with evidence of thyroid disease will be
referred to thyroid specialists at the Semipalatinsk State Medical Academy. Finger stick
blood samples will be obtained to assess thyroid function using RIA methods with coated tube
technology for T4 and TSH. The most sensitive statistical comparisons are expected to be
dose-response analyses with respect to prevalence of thyroid nodules, which are common and
known to be associated with radiation dose. Comparisons in terms of thyroid cancer, and
benign and malignant neoplasms combined, are likely to be less sensitive but of acceptable
power if risks associated with chronic radiation in this population are similar to those
associated with acute exposure to X-ray or gamma radiation in other populations.
Status | Completed |
Enrollment | 2997 |
Est. completion date | November 18, 2016 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 63 Years to 71 Years |
Eligibility |
- INCLUSION CRITERIA: Subjects will be selected in accordance with the research aims of the project. The majority should have whole-body or bone marrow radiation dose estimates as high as available among subjects who were children at the time of the major fallout events. Few presumably low-exposure subjects are needed as null controls. All subjects should have been born between 1940 and 1948. EXCLUSION CRITERIA: Subjects must not have a medical history including radiation therapy or high-dose diagnostic radiography or been treated for cancer. |
Country | Name | City | State |
---|---|---|---|
Kazakhstan | Semipalatinsk State Medical Academy | Semipalatinsk |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
Kazakhstan,
Gusev BI, Abylkassimova ZN, Apsalikov KN. The Semipalatinsk nuclear test site: a first assessment of the radiological situation and the test-related radiation doses in the surrounding territories. Radiat Environ Biophys. 1997 Sep;36(3):201-4. — View Citation
Hall P, Holm LE. Cancer in iodine-131 exposed patients. J Endocrinol Invest. 1995 Feb;18(2):147-9. — View Citation
Laird NM. Thyroid cancer risk from exposure to ionizing radiation: a case study in the comparative potency model. Risk Anal. 1987 Sep;7(3):299-309. — View Citation
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