Study of Radiation Exposure in Chernobyl Clean-up Workers With Leukemia, Multiple Myeloma, or Myelodysplasia - Full Text View

Sponsor:	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	Other: questionnaire administration

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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

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

U.S. FDA Resources

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Maureen Hatch, PhD

National Cancer Institute (NCI)

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000566036, NCI-OH96-C-N030
Study First Received:	November 15, 2007
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00558974 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

leukemia
multiple myeloma
myelodysplastic syndromes

Additional relevant MeSH terms:

Disease
Immunoproliferative Disorders
Neoplasms by Histologic Type
Precancerous Conditions
Immune System Diseases
Hematologic Diseases
Blood Protein Disorders
Myelodysplastic Syndromes
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Multiple Myeloma
Leukemia
Neoplasms
Preleukemia
Pathologic Processes
Hemorrhagic Disorders
Syndrome
Cardiovascular Diseases
Bone Marrow Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on November 30, 2009