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Study of Radiation Exposure in Chernobyl Clean-up Workers With Leukemia, Multiple Myeloma, or Myelodysplasia
This study is currently recruiting participants.
Study NCT00558974   Information provided by National Cancer Institute (NCI)
First Received: November 15, 2007   Last Updated: August 11, 2009   History of Changes

November 15, 2007
August 11, 2009
July 1996
 
Association between dose of radiation and increased risk of leukemia in the liquidators at Chernobyl
Same as current
Complete list of historical versions of study NCT00558974 on ClinicalTrials.gov Archive Site
  • Relationship between dose and clinical response in the liquidators at Chernobyl
  • Modifiers of risk in the liquidators at Chernobyl
  • Association between dose of radiation and increased risk of multiple myeloma in the liquidators at Chernobyl
  • Association between dose of radiation and increased risk of myelodysplasia in the liquidators at Chernobyl
Same as current
 
Study of Radiation Exposure in Chernobyl Clean-up Workers With Leukemia, Multiple Myeloma, or Myelodysplasia
Scientific Protocol for the Study of Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident

RATIONALE: Studying the amount of radiation that patients were exposed to during the clean-up following the Chernobyl nuclear accident may help doctors learn more about the risks of developing leukemia, multiple myeloma, and myelodysplasia.

PURPOSE: This clinical trial is studying the effect of radiation exposure on patients with leukemia, multiple myeloma, or myelodysplasia who were clean-up workers after the Chernobyl nuclear power plant accident.

OBJECTIVES:

Primary

  • To test the hypothesis that there is a dose-related increase in risk of leukemia in the liquidators involved in the cleanup work after the Chernobyl Nuclear Power Plant accident in northern Ukraine in 1986.
  • To test the hypothesis that the magnitude of any observed risk per unit dose in these participants is less than that seen in the atomic bomb survivors, who were exposed to essentially instantaneous radiation.

Secondary

  • To investigate the nature of dose-response relationship in these participants.
  • To identify modifiers of risk (e.g., time since exposure and age at exposure) in these participants.
  • To test the hypothesis that there is a dose-related increase in risk of multiple myeloma in these participants.
  • To test the hypothesis that there is a dose-related increase in risk of myelodysplasia in these participants.

OUTLINE: Study participants undergo an interview and complete a questionnaire to provide information on personal and family medical histories and occupational exposure to radiation. Participants who are deceased are evaluated via interviews with spouses or other close relatives to obtain medical histories as well as names of co-workers at Chernobyl. Dose estimates of radiation exposure due to the Chernobyl accident or to medical sources of radiation (i.e., CT scans or radiopharmaceuticals) are made during the dosimetry portion of the interview.

 
Observational
 
  • Leukemia
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
Other: questionnaire administration
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1000
 
 

DISEASE CHARACTERISTICS:

  • Diagnosis of leukemia, multiple myeloma, or myelodysplasia based on retrospective review of cohort records linked to the Ukranian Cancer Registry AND meets 1 of the following criteria:

    • Member of a cohort of approximately 100,000 Ukranian liquidators involved as clean-up workers after the nuclear accident at Chernobyl Nuclear Power Plant in northern Ukraine in 1986 AND meets the following criteria:

      • In first year of service as a liquidator between the years 1986-1990
      • Resident (when first registered in the Chernobyl State Registry) of Kiev City or in one of five oblasts (i.e., major civil divisions) that comprise the study area, including Cherkasy, Dnipropetrovsk, Chenihiv, Kiev, and Kharkiv
      • Under 60 years old at the time of employment at Chernobyl
      • Not necessarily alive at selection
    • Matched control patient
  • Received mean bone marrow doses of approximately 80-100 milligray at low to moderate dose rates

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
18 Years and older
Yes
 
Ukraine
 
NCT00558974
 
CDR0000566036, NCI-OH96-C-N030
National Cancer Institute (NCI)
 
Principal Investigator: Maureen Hatch, PhD National Cancer Institute (NCI)
National Cancer Institute (NCI)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP