Thyroid Cancer Among Chornobyl Clean-up Workers in Ukraine: Pilot Study



Status:Recruiting
Conditions:Cancer, Cancer, Endocrine, Thyroid Cancer
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:18 - 65
Updated:3/16/2015
Start Date:December 2010
Contact:Kiyohiko Mabuchi, M.D.
Email:mabuchik@mail.nih.gov
Phone:(301) 594-7649

Use our guide to learn which trials are right for you!

Background:

- The Ukrainian Research Center for Radiation Medicine and the U.S. National Institutes of
Health have been studying cancer risks and outcomes in individuals who participated in the
decontamination clean-up process following the Chornobyl nuclear accident. Some of these
individuals were exposed to external radiation at various levels, as well as radioactive
iodine that may have affected the thyroid and increased the risk of developing thyroid
cancer. Because more individual and comparative data are needed on the affected populations
and clean-up workers associated with the Chornobyl accident, researchers are interested in
collecting personal information and saliva samples from Chornobyl clean-up workers who have
been diagnosed with thyroid cancer.

Objectives:

- To assess the radiation-related risk of thyroid cancer among male Chornobyl clean-up
workers and collect saliva samples for an initial study.

Eligibility:

- Male Chornobyl clean-up workers from Kyiv and Donetsk oblasts who have been diagnosed with
thyroid cancer.

Design:

- Participants will complete a standardized questionnaire during a personal interview.
The questionnaire will ask for detailed information on the following areas of study:

- Work history, conditions, and activities inside the 70-km clean-up and radiation
calculation zone.

- Residence history inside and outside the 30-km exclusion zone.

- Milk consumption between April 26 and June 30, 1986 (to assess radioactivity from
radioiodine fallout).

- Potential non-radiation risk factors for thyroid cancer (e.g., smoking, alcohol
consumption, family cancer history).

- Participants will provide a saliva sample for pilot study testing.

Background:

Much is known about the radiation-related risk of thyroid cancer, but there is considerable
uncertainty about the magnitude of the radiation risk among those who were exposed as
adults, particularly in males. A large number of clean-up workers, mostly male, who
participated in decontamination and clean-up activities after the Chornobyl accident were
exposed to external radiation at various levels. An increased thyroid cancer risk has been
reported from studies of Russian, Estonian and Latvian clean-up workers, but there is little
evidence of a dose response. However, recent published data from an IARC study of thyroid
cancer cases and controls pooled from the Chornobyl clean-up workers in Belarus, Russia and
Baltic countries show a strong dose response with an estimated risk per unit dose that is
much higher than those reported from other irradiated populations exposed as adults.
Following the completion of our NCI study of leukemia among Ukrainian clean-up workers, we
are proposing a nested case-control study to assess the radiation-related risk of thyroid
cancer among the 150,000 male cleanup workers in Ukraine. In preparation for this study, a
pilot study is in progress to assess the feasibility of a full study.

Objectives:

The objectives are (i) to identify thyroid cancer cases and demographically matched controls
without thyroid cancer occurring among the 150,000 Ukrainian clean-up workers through
linkage to the National Cancer Registry and Chernobyl State Registry of Ukraine; (ii) to
trace/locate and interview a small sample of subjects with thyroid cancer and their
respective controls ; (iii) to obtain saliva buccal cell samples; and (iv) to locate and
transfer thyroid tumor specimens from identified cases to the archive maintained at the
Research Center for Radiation Medicine (RCRM),for diagnostic verification and possible
future genetic/molecular research using the latest available techniques.

Eligibility:

The cohort includes Ukrainian clean-up workers who meet the following eligibility criteria:
males, first year of service as a clean-up worker (1986-1990); initial registration as a
clean-up worker in one of the study areas; and age when first worked in the Chornobyl zone
(under 60). For the pilot study, we will select 100-110 cases with thyroid cancer in three
study areas, Kyiv, Donetsk and Dnipropetrovsk oblasts and controls (with a case-control
ratio of 1:3). We will assess the feasibility of proxy interview for deceased thyroid cancer
cases in the study area.

Design:

This pilot study will be conducted in the framework of the planned nested case-control study
in the cohort of Chornobyl clean-up workers but will involve only a small number of subjects
with thyroid cancer and their respective controls. Thyroid cancer cases will be identified
by linkage to the Cancer Registry of Ukraine. Controls will be identified from the Chernobyl
State Registry. Locating archived tumor tissues will be done by search of the Cancer
Registry of Ukraine database supplemented by interview data. Consent for transfer of tissues
to RCRM will be sought at the time of interview.

- INCLUSION CRITERIA:

For the pilot study, we will select clean-up workers with thyroid cancer reported in three
study areas, Kyiv, Donetsk and Dnipropetrovsk oblasts and controls (with a case-control
ratio of 1:3) demographically matched to cases. We estimate the number of these cases will
be between 100 and 110. These two oblasts have been chosen to represent an area known,
from the leukemia study, to have a high study participation rate (Kyiv and Dnipropetrovsk
oblasts) and an area newly added and thus unknown regarding participation rate (Donetsk).
All study subjects are males and average about 55 years. In view of the very high survival
rate for thyroid cancer, a majority of the subjects are expected to be alive.

EXCLUSION CRITERIA:

Excluded from the study will be those who cannot be located, refuse to participate in the
study, or do not provide informed consent.
We found this trial at
1
site
9609 Medical Center Drive
Bethesda, Maryland 20892
1-800-422-6237
National Cancer Institute , 9000 Rockville Pike The National Cancer Institute (NCI) is part of...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials