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

This study is currently recruiting participants.
Verified April 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01265381
First received: December 22, 2010
Last updated: May 11, 2013
Last verified: April 2013
  Purpose

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.

Condition
Thyroid Cancer

Study Type: Observational
Official Title: Thyroid Cancer Among Chornobyl Clean-up Workers in Ukraine: Pilot Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 550
Study Start Date: December 2010
Detailed Description:

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 clean-up workers in Ukraine. In preparation for this study, we plan to conduct a pilot study 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; (iii) to obtain saliva buccal cell samples; and (iv) to obtain information on availability of archival thyroid tumor specimens for future tumor-tissue collection.

ELIGIBILITY:

The cohort includes Ukrainian clean-up workers with the following eligibility criteria: males, first year of service as a clean-up worker (1986-2006); initial registration as a clean-up worker in one of the study areas; and age when first worked at Chornobyl (under 60). For the pilot study, we will select 100-110 cases with thyroid cancer in three study areas, Kyiv, Donetck and Dnipropetrovsk oblasts and controls (with a 4:1 ratio).We will access 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. 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 registry database.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • 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 4:1 ratio, without thyroid cancer) demographically matched to cases. We estimate the number of these cases will be between 30 and 40. 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265381

Contacts
Contact: Kiyohiko Mabuchi, M.D. (301) 594-7649 mabuchik@mail.nih.gov

Locations
United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: Kiyohiko Mabuchi, M.D.     301-594-7649     mabuchik@mail.nih.gov    
Sponsors and Collaborators
Investigators
Principal Investigator: Kiyohiko Mabuchi, M.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01265381     History of Changes
Other Study ID Numbers: 999911049, 11-C-N049
Study First Received: December 22, 2010
Last Updated: May 11, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Ukraine
Cohort
Radiation
Thyroid Cancer

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013