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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.
Verified by National Cancer Institute (NCI), March 2008

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00558974
  Purpose

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.


Condition Intervention
Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Procedure: questionnaire administration

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Multiple Myeloma   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Scientific Protocol for the Study of Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident

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

Primary Outcome Measures:
  • Association between dose of radiation and increased risk of leukemia in the liquidators at Chernobyl

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   1000
Study Start Date:   July 1996

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558974

Locations
Ukraine
Research Centre for Radiation Medicine     Recruiting
      Kiev, Ukraine, 254050
      Contact: Anatoly Romanenko, MD     Not Available        

Sponsors and Collaborators

Investigators
Principal Investigator:     Maureen Hatch, PhD     National Cancer Institute (NCI)    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000566036, NCI-OH96-C-N030
First Received:   November 15, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00558974
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
leukemia  
multiple myeloma  
myelodysplastic syndromes  

Study placed in the following topic categories:
Myelodysplastic syndromes
Immunoproliferative Disorders
Precancerous Conditions
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Myelodysplasia
Myelodysplastic Syndromes
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Leukemia
Preleukemia
Hemorrhagic Disorders
Multiple myeloma
Bone Marrow Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type
Immune System Diseases
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 07, 2008




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