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| Tracking Information | |||||
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| First Received Date ICMJE | November 15, 2007 | ||||
| Last Updated Date | August 11, 2009 | ||||
| Start Date ICMJE | July 1996 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Association between dose of radiation and increased risk of leukemia in the liquidators at Chernobyl | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00558974 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Radiation Exposure in Chernobyl Clean-up Workers With Leukemia, Multiple Myeloma, or Myelodysplasia | ||||
| Official Title ICMJE | Scientific Protocol for the Study of Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident | ||||
| Brief Summary | 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE | Other: questionnaire administration | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | Ukraine | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00558974 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000566036, NCI-OH96-C-N030 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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