Thyroid Cancer Clinical Trial
Official title:
Studies of Thyroid Abnormalities in Northeastern Kazakhstan Associated With Nuclear Weapons Testing
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.
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, and electron paramagnetic resonance (EPR) assays of about 110
stored tooth samples. The two techniques are complementary. 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 EPR investigation will take advantage of a repository of teeth extracted by local
dentists during medical and dental programs in 1966-67 and 1999, stored, and catalogued by
our collaborators in Kazakhstan (not in connection with this study). Tooth samples are
identified by village of exposure, but not individually within villages. However, the
identities of the donors, and therefore their ages and exposure histories, are known to our
collaborators in Kazakhstan; therefore it will be possible to compare the EPR results with
gamma dose estimates calculated on the basis of exposure history. It is intended that the EPR
assays will be carried out at the National Institute of Standards and Technology under a
purchase order agreement.
The second part will involve thyroid screening by ultrasound in selected villages. The
population to be screened will comprise 1000-1500 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.
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