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Sponsor study identifier
Secondary identifiers
observational
1,779
1 country
1
Study Start
August 26, 1996
Actual (reported)Primary Completion
February 12, 2020
Actual (reported)Study Completion
February 12, 2020
Actual (reported)Leukemia holds a special place in the study of radiation-related cancer because bone marrow is one of the tissues most sensitive to the carcinogenic effect of ionizing radiation, radiogenic leukemia has the shortest latent period among radiation-induced cancers, and its appearance suggests that solid tumors may follow. These same characteristics also contribute to its considerable significance in radiation protection. There are, nevertheless, important gaps in existing knowledge of radiation-induced leukemia, gaps that derive from characteristics of the study of the atomic bombing of Hiroshima and Nagasaki, and from studies of the effects of medical irradiation and studies of nuclear workers, these being the studies that have provided most of the information to date. These gaps include the presumed reduction in risk resulting from dose-fractionation and low dose-rate, and the time-response function in the first five years after exposure. The primary objective of this study is to investigate leukemia risk as a function of such radiation; it would constitute the largest epidemiologic study conducted to date among working-age males, a group of particular concern in establishing occupational radiation safety standards. In addition, data on cases of multiple myeloma and myelodysplasia identified in the cohort will be collected to test the hypothesis of a dose related association between radiation and increased risk for each of these diseases. The primary scientific objectives of the proposed study are to test the following hypotheses: (a) that there is a dose-related increase in risk of leukemia among these liquidators; (b) that the magnitude of any observed risk per unit dose is less than that seen in the atomic bomb survivors, exposed to essentially instantaneous radiation. Subsidiary objectives include: (a) to investigate the nature of the dose-response relationship among liquidators and to identify modifiers of risk, including time since exposure, age at exposure, etc.; (b) to test the hypothesis that there is a dose-related increased risk of multiple myeloma; (c) to test the hypothesis that there is a dose-related increased risk of myelodysplasial; (d) to collect and store buccal cells from about 2,000 liquidators with a wide range of dose estimates extending to well over 1 Gy for possible use in future molecular studies of their DNA.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 12, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 26, 1996
Actual (reported)June 19, 2006
Actual (reported)June 21, 2006
Actual (reported)February 12, 2020
Actual (reported)February 12, 2020
Actual (reported)The primary objective of this study is to investigate leukemia risk as a function of radiation ionizing radiation from occupational exposure (Chernobyl nuclear power plant)
Estimated risk of leukemia related to radiation exposure
time of interview
Cases with leukemia and related diseases, and matched controls in the cohort
Ukrainian Chernobyl cleanup workers ("liquidators") approx. 100,000 persons
Research Center for Radiation Medicine
Kiev, Ukraine
Gudzenko N, Hatch M, Bazyka D, Dyagil I, Reiss RF, Brenner A, Chumak V, Babkina N, Zablotska LB, Mabuchi K. Non-radiation risk factors for leukemia: A case-control study among chornobyl cleanup workers in Ukraine. Environ Res. 2015 Oct;142:72-6. doi: 10.1016/j.envres.2015.06.019. Epub 2015 Jun 24.
Chumak VV, Romanenko AY, Voilleque PG, Bakhanova EV, Gudzenko N, Hatch M, Zablotska LB, Golovanov IA, Luckyanov NK, Sholom SV, Kryuchkov VP, Bouville A. The Ukrainian-American study of leukemia and related disorders among Chornobyl cleanup workers from Ukraine: II. Estimation of bone marrow doses. Radiat Res. 2008 Dec;170(6):698-710. doi: 10.1667/RR1403.1.
Kiyohiko Mabuchi, M.D.
National Cancer Institute (NCI)
1,779 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
August 26, 1996
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
Zablotska LB, Bazyka D, Lubin JH, Gudzenko N, Little MP, Hatch M, Finch S, Dyagil I, Reiss RF, Chumak VV, Bouville A, Drozdovitch V, Kryuchkov VP, Golovanov I, Bakhanova E, Babkina N, Lubarets T, Bebeshko V, Romanenko A, Mabuchi K. Radiation and the risk of chronic lymphocytic and other leukemias among chornobyl cleanup workers. Environ Health Perspect. 2013 Jan;121(1):59-65. doi: 10.1289/ehp.1204996. Epub 2012 Nov 8.
February 12, 2020
Actual (reported)Study Completion
February 12, 2020
Actual (reported)Last Updated
February 21, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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