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

NCT01265381 | Terminated

• 2 other identifiers: 99991104911-C-N049
• Study Type: observational
• Target: 673
• Locations: 1 country
• Sites: 1

Brief Summary

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....

Conditions

Thyroid Cancer

Keywords

Cohort; Radiation; Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• To assess the radiation - related risk of thyroid cancer among the 150,000 male clean-up workers in Ukraine

  Risk of thyroid cancer attributable to radiation

  At time of analysis completion

Study Arms (1)

Cohort of Chernobyl Cleanup Workers in Ukraine

Thyroid cancer cases and matched controls in the cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ukrainian Chernobyl clean-up workers ("liquidators") approx. 150,000

You may qualify if:

• 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.

You may not qualify if:

• Excluded from the study will be those who cannot be located, refuse to participate in the study, or do not provide informed consent.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Research Center for Radiation Medicine

Kiev, Ukraine

Location

Related Publications (3)

• Mabuchi K, Hatch M, Little MP, Linet MS, Simon SL. Risk of thyroid cancer after adult radiation exposure: time to re-assess? Radiat Res. 2013 Feb;179(2):254-6. doi: 10.1667/RR3121.1. Epub 2012 Dec 19.

  PMID: 23252377 BACKGROUND

• Ostroumova E, Gudzenko N, Brenner A, Gorokh Y, Hatch M, Prysyazhnyuk A, Mabuchi K, Bazyka D. Thyroid cancer incidence in Chornobyl liquidators in Ukraine: SIR analysis, 1986-2010. Eur J Epidemiol. 2014 May;29(5):337-42. doi: 10.1007/s10654-014-9896-1. Epub 2014 Apr 5.

  PMID: 24705729 BACKGROUND

• Kesminiene A, Evrard AS, Ivanov VK, Malakhova IV, Kurtinaitise J, Stengrevics A, Tekkel M, Chekin S, Drozdovitch V, Gavrilin Y, Golovanov I, Kryuchkov VP, Maceika E, Mirkhaidarov AK, Polyakov S, Tenet V, Tukov AR, Byrnes G, Cardis E. Risk of thyroid cancer among chernobyl liquidators. Radiat Res. 2012 Nov;178(5):425-36. doi: 10.1667/RR2975.1. Epub 2012 Sep 21.

  PMID: 22998226 BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Kiyohiko Mabuchi, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 23, 2010
• Study Start: December 22, 2010
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: March 3, 2020

Record last verified: 2019-03

Locations

UA (1)