New York, New York 10032

  • Unspecified Adult Solid Tumor, Protocol Specific

Purpose:

RATIONALE: Collecting and studying samples of blood from workers exposed to high doses of radiation may help the study of cancer in the future. PURPOSE: This clinical trial is studying gene changes and risk factors in nuclear workers in Mayak, Russia.


Study summary:

OBJECTIVES: - Assess genetic polymorphism contribution in stable chromosome aberration frequency in nuclear workers in Mayak, Russia exposed to high-doses of radiation. OUTLINE: This is a multicenter study. Blood samples are collected annually during routine medical exams to assess intermediate biomarkers of radiation exposure. Samples are analyzed by mBAND biodosimetry and mFISH to measure intrachromosomal aberrations. Germline genetic variation in DNA repair and other genes is also assessed as a risk factor for chromosomal aberration frequency. Participants complete a short questionnaire assessing their jobs, as well as history of family health, smoking and alcohol consumption, and benign tumors, if any. Additional information is obtained from participants' medical records.


Criteria:

DISEASE CHARACTERISTICS: - Meets one of the following criteria: - Nuclear worker in Mayak, Russia who has had notable and atypical radiation exposure - Employed from 1948 to 1972 in 1 of 3 Ozyorsk plants directly related to nuclear weapon production - Remains a local resident - Estimates of external gamma dose and internal plutonium exposure available - Workers who did not have any plutonium exposure are still eligible due to their external radiation exposure - Current or former worker in auxiliary plant (water treatment plant or mechanical repair plant) at the Mayak facility - Cancer-free - No Tartars or Bashkirs PATIENT CHARACTERISTICS: - See Disease Characteristics PRIOR CONCURRENT THERAPY: - No radiation therapy or blood transfusion within the past year


Study is Available At:


Original ID:

CDR0000551642


NCT ID:

NCT01338168


Secondary ID:

NCI-04-C-N215


Study Acronym:


Brief Title:

Gene Changes and Risk Factors in Nuclear Workers in Mayak, Russia


Official Title:

Germline Genetic Variation and Risk of Chromosome Aberrations Among Mayak Nuclear Workers


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

357


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Elaine Ron, MD
Study Chair
National Cancer Institute (NCI)

Study Dates

Start Date:June 2004
Verification Date:July 2009
Last Changed Date:April 16, 2011
First Received Date:April 16, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Genetic polymorphism contribution in stable chromosome aberration frequency
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:questionnaire administration
Intervention Type:Other
Name:medical chart review
Intervention Type:Other
Name:laboratory biomarker analysis
Intervention Type:Genetic
Name:polymorphism analysis
Intervention Type:Genetic
Name:mutation analysis
Intervention Type:Genetic
Name:fluorescence in situ hybridization

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 21, 2023

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