Relationship of Genetic Differences to the Development of Chromosome Abnormalities
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|ClinicalTrials.gov Identifier: NCT00481793|
Recruitment Status : Terminated
First Posted : June 4, 2007
Last Update Posted : December 17, 2019
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This is a collaborative study by the National Cancer Institute, Columbia University, and the Southern Urals Biophysics Institute in Russia. It will examine the relationship of differences in certain genes to the development of chromosomal abnormalities in workers at the Mayak nuclear production plant in Ozyorsk, Russia. This population was exposed to higher radiation doses from external and internal sources than those received by their counterparts in other countries or considered permissible today. If a risk relationship is found between genetic differences and chromosome abnormalities, the information might be useful in studies designed to examine how high radiation exposures cause cancer.
Radiation-exposed Mayak workers employed from 1948 to 1972 in the three Ozyorsk plants directly related to nuclear weapons production may be eligible for this study. They must have remained local residents in the area and estimates of their external and internal radiation exposures must be available.
Participants provide a blood sample for genetic studies and answer a questionnaire that includes demographic information and information about their family health history, history of benign tumors, if any, and history of smoking and alcohol consumption. Additional information is collected from patients' medical records.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||361 participants|
|Official Title:||Germline Genetic Variation and Risk of Chromosome Aberrations Among Mayak Nuclear Workers|
|Study Start Date :||June 9, 2004|
|Study Completion Date :||September 17, 2014|
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- INCLUSION CRITERIA - EXPOSED POPULATION:
Individuals eligible to be included in the 'exposed' population include all those employed from 1948-1972 in the three plants directly related to nuclear-weapon production (nuclear reactor, radiochemical production plant, plutonium production plant), who have remained local residents, and who have estimates of their external gamma dose and internal plutonium exposure.
Some eligible workers did not have any plutonium exposure, but are still eligible to be included in the exposed sample due to their external radiation exposure.
All participants are required to be cancer-free at the time of enrollment.
EXCLUSION CRITERIA - EXPOSED POPULATION:
Individuals who have a medical history of radiation therapy or a blood transfusion within the previous year will be excluded.
As the sample size would not be adequate to examine their risk separately, Tartars and Bashkirs will not be included in the study.
INCLUSION CRITERIA - COMPARISON GROUP:
The comparison population will be drawn from current and former workers in the auxiliary plants (water treatment facility and mechanical repair plant) at the Mayak facility.
Included will be a stratified random sample of these workers who were employed from 1948-1972, who have remained local residents, and who have estimates of their external gamma dose.
Individuals selected will be frequency-matched according to age (5 year age groups) and gender to the exposed worker population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481793
|Southern Urals Biophysics Institute|
|Ozyorsk, Russian Federation|
|Principal Investigator:||Martha Linet, M.D.||National Cancer Institute (NCI)|
|Obsolete Identifiers:||NCT00342901, NCT01338168|
|Other Study ID Numbers:||
|First Posted:||June 4, 2007 Key Record Dates|
|Last Update Posted:||December 17, 2019|
|Last Verified:||September 17, 2014|