Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Disease in Ukraine Following the Chernobyl Accident

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00341094
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

The nuclear power plant accident at Chornobyl released large quantities of Iodine-131 and other radioisotopes of iodine in the atmosphere, contaminating thousands of square kilometers and exposing millions of people. For this study, a well-defined subset of Ukrainian children aged 0-18 years or in utero at the time of the accident are being identified and examined by well-trained specialists for thyroid disease every two years for at least three cycles. The study is a collaborative effort of research in Ukraine and the United States.

The cohort will include approximately 13,000 persons who were children in 1986, all or most of whom have had their thyroids measured for radioactivity during the weeks immediately following the accident (or whose mothers had measurements taken while the child was in utero). Under a rigid research protocol these subjects will receive diagnostic thyroid examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory tests, and, if indicated, fine-needle aspiration biopsy. Interview information regarding residential, health, diet and lifestyle history will also be collected. All subjects will be followed for thyroid cancer morbidity and mortality. Thyroid cancers will be confirmed by expert pathology examination of tissue.

In addition to the analysis of thyroid radiation measurements made in May-June, 1986, efforts will be made to reconstruct each person's exposure and to estimate the radiation dose to the thyroid. This will involve the reconstruction of deposition patterns and environmental pathways of the radioiodines, and of the location, dietary characteristics, and lifestyle of each person throughout the exposure period.

The aim of the study is to carry out valid and credible assessments of the early and late morphologic and functional changes in the thyroid glands of persons exposed to radiation from radioactive materials released as a consequence of the Chornobyl nuclear power plant accident. The emphasis is on dose- and time-specific changes.

In the course of the study other possible risk factors will be examined including dietary iodine intake during and after 1986, and the ingestion of potassium iodide for thyroid protection shortly after the accident.


Condition
Thyroid Cancer
Thyroid Disease

Study Type: Observational
Official Title: Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Diseases in Ukraine Following the Chernobyl Accident

Resource links provided by NLM:


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

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

The nuclear power plant accident at Chornobyl released large quantities of Iodine-131 and other radioisotopes of iodine into the atmosphere, contaminating thousands of square kilometers and exposing millions of people. For this study, a well-defined subset of Ukrainian children aged less than 18 years or in utero at the time of the accident were identified and have been examined by well-trained specialists. The main cohort was screened for thyroid disease every two years for 4 cycles ending in April, 2007. The in utero cohort was screened once, between 2003-2006. The study is a collaborative effort of researchers in Ukraine and the United States.

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The main cohort includes approximately 13,000 persons who were children in 1986, all or most of whom had their thyroids measured for radioactivity during the weeks immediately following the accident. Under a rigid research protocol, these subjects received diagnostic thyroid examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory tests. If indicated, they were referred for a fine-needle aspiration biopsy. Interview information regarding residential, health, diet and lifestyle history will also be collected. All subjects are followed for thyroid cancer morbidity and mortality. Thyroid cancers are confirmed by expert pathology examination of tissue obtained during surgery. The in utero cohort includes a total of 2,582 individuals. In addition starting in 2003, ~ 7,000 parents of members of the main cohort who were under age 10 y at the time of the accident were interviewed in order to increase the accuracy of recall. These individuals were listed as new subjects. Altogether, 23,143 individuals have been accrued in this study.

In addition to the analysis of thyroid radiation measurements made in May-June, 1986, radiation dose to the thyroid was estimated drawing on such data as the reconstruction of deposition patterns and environmental pathways of the radioiodines, and of the location, dietary characteristics, and lifestyle of each person throughout the exposure period. For in utero subjects, fetal dose was estimated based on the mother s thyroid dose.

The aim of the study is to assess the early and late morphologic and functional changes in the thyroid glands of persons exposed at young ages to radiation from radioactive materials released as a consequence of the Chornobyl nuclear power plant accident, with emphasis on dose-and time-specific changes. 110 cancers were identified in the main cohort, and 8 confirmed or suspect cases were diagnosed among those exposed in utero. Active thyroid screening ended in April, 2007, but data analyses are being actively pursued.

There have been three scientific amendments to the protocol: transition cancer case ascertainment to a passive form of follow-up based on linkage to the National Cancer Registry of Ukraine (NCRU); a sub-study involving an additional follow-up examination of those cohort members who were diagnosed with benign nodular thyroid pathology during one of the earlier four active screening cycles; and genetic studies (gene expression and germline SNP studies) of thyroid cancer in this Ukrainian cohort exposed to radioiodines from Chornobyl fallout as children or adolescents. Work is continuing to complete the linkage follow-up, nodule follow-up and blood sample collection.

  Eligibility

Ages Eligible for Study:   up to 34 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Sample selection in Belarus consists of all children who were born between 26 April 1968 and 26 April 1986 and had their thyroid radio-activity measured in 1986 shortly after the accident.

Sample selection in Ukraine consists of all children who were born between 26 April 1968 and 26 April 1986 and had their thyroid radio-activity measured in 1986 shortly after the accident.

Sample from Ukraine lived at least part of the time between 26 April and 30 June 1986 in the town of Pripyat or in one of the 8 most contaminated raions (Ivankivskyi, Chornobylskyi, and Poliskyi raiions in the Kyiv Oblast; Narodychskyi and Ovruchskyi in Zhitomyr Oblast; Repkinsky. Kozeletskyi, and Chernihivskyi in Chernihiv Oblast).

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00341094

Locations
Ukraine
Academy of Medical Science
Kiev, Ukraine
Sponsors and Collaborators
Investigators
Principal Investigator: Kiyohiko Mabuchi, M.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00341094     History of Changes
Obsolete Identifiers: NCT00558610, NCT01338259
Other Study ID Numbers: 999995020, OH95-C-N020
Study First Received: June 19, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

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

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 September 14, 2014