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Studies of Thyroid Abnormalities in Northeastern Kazakhstan Associated With Nuclear Weapons Testing

NCT00341185 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2997

Last updated 2019-12-16

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kiyohiko Mabuchi, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
63 Years
Max Age
71 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-03-05
Completion
2016-11-18

Countries

  • Kazakhstan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00341185 on ClinicalTrials.gov