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Studying Thyroid Cancer and Other Thyroid Diseases in Participants Who Were Children in Ukraine During the Chernobyl Nuclear Power Plant Accident
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2008
First Received: November 14, 2007   Last Updated: February 6, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00558610
  Purpose

RATIONALE: Measuring changes in the thyroid gland after radiation exposure may help doctors learn about the long-term effects of radiation exposure and help the study of thyroid cancer and other thyroid diseases.

PURPOSE: This clinical trial is studying thyroid cancer and other thyroid diseases in participants who were children in Ukraine during the Chernobyl nuclear power plant accident.


Condition Intervention
Head and Neck Cancer
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: fine-needle aspiration
Procedure: observation
Procedure: study of high risk factors
Procedure: ultrasound imaging

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy Thyroid Cancer Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources
Study Type: Observational
Official Title: Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Diseases in Ukraine Following the Chernobyl Accident

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Changes in the thyroid gland after radiation exposure from the Chernobyl nuclear power plant accident in 1986
  • Examination of other possible risk factors, including dietary iodine intake during and after 1986 and the ingestion of potassium iodide for thyroid protection shortly after the accident

Estimated Enrollment: 70000
Study Start Date: May 1995
Detailed Description:

OBJECTIVES:

  • Carry out valid and credible assessments of the early and late morphologic and functional changes in the thyroid glands of individuals exposed to radiation from radioactive materials released as a result of the Chernobyl nuclear power plant accident in 1986.
  • Examine other possible risk factors, including dietary iodine intake during and after 1986 and the ingestion of potassium iodide for thyroid protection shortly after the accident.

OUTLINE: Participants complete a questionnaire about residence (at the time of the Chernobyl nuclear power plant accident), health, diet, lifestyle, and family history of thyroid disease. Participants also undergo diagnostic thyroid examinations, including palpation, ultrasound scanning, and thyroid hormone and other laboratory testing. Fine-needle aspirations are performed, if indicated. Some participants may also undergo urine sample collection to determine urinary iodine content. Participants are reexamined every 2 years for at least 6 years for thyroid cancer morbidity and mortality.

If the participant was under 10 years of age at the time of the nuclear power plant accident (or if the mother was pregnant with the participant at the time of the accident), the questionnaire is completed by the participant's parents.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Resident of Ukraine at the time of the Chernobyl nuclear power plant accident in 1986

    • Under 18 years of age or in utero at the time of the accident
  • Exposed to radiation from the accident

    • Had thyroid measured for radioactivity in the weeks immediately following the accident (or mother had thyroid measurements taken while the participant was in utero)

PATIENT CHARACTERISTICS:

  • See Disease Characteristics

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558610

Locations
Ukraine
Research Centre for Radiation Medicine Recruiting
Kiev, Ukraine, 254050
Contact: Iiya Likhtarev, PhD     Not Available        
Ukrainian Research Institute of Endocrinology & Metabolism Recruiting
Kiev, Ukraine, 252114
Contact: Mykola Tronko, MD     380-44-430-3694     office@thyroid.kiev.ua    
Sponsors and Collaborators
Investigators
Principal Investigator: Maureen Hatch, PhD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000566084, NCI-OH95-C-N020
Study First Received: November 14, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00558610     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
thyroid cancer

Study placed in the following topic categories:
Thyroid Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Endocrinopathy
Thyroid Diseases
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on May 07, 2009