Relationship of Genetic Differences to the Development of Chromosome Abnormalities

NCT00481793 | Terminated

• 2 other identifiers: 99990421504-C-N215
• Study Type: observational
• Target: 361
• Locations: 1 country
• Sites: 1

Brief Summary

This is a collaborative study by the National Cancer Institute, Columbia University, and the Southern Urals Biophysics Institute in Russia. It will examine the relationship of differences in certain genes to the development of chromosomal abnormalities in workers at the Mayak nuclear production plant in Ozyorsk, Russia. This population was exposed to higher radiation doses from external and internal sources than those received by their counterparts in other countries or considered permissible today. If a risk relationship is found between genetic differences and chromosome abnormalities, the information might be useful in studies designed to examine how high radiation exposures cause cancer. Radiation-exposed Mayak workers employed from 1948 to 1972 in the three Ozyorsk plants directly related to nuclear weapons production may be eligible for this study. They must have remained local residents in the area and estimates of their external and internal radiation exposures must be available. Participants provide a blood sample for genetic studies and answer a questionnaire that includes demographic information and information about their family health history, history of benign tumors, if any, and history of smoking and alcohol consumption. Additional information is collected from patients' medical records. ...

Conditions

Radiation Exposure

Keywords

Plutonium; Ionizing Radiation; Polymorphism; Biological Marker; Russia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals eligible to be included in the 'exposed' population include all those employed from 1948-1972 in the three plants directly related to nuclear-weapon production (nuclear reactor, radiochemical production plant, plutonium production plant), who have remained local residents, and who have estimates of their external gamma dose and internal plutonium exposure.
• Some eligible workers did not have any plutonium exposure, but are still eligible to be included in the exposed sample due to their external radiation exposure.
• All participants are required to be cancer-free at the time of enrollment.

You may not qualify if:

• Individuals who have a medical history of radiation therapy or a blood transfusion within the previous year will be excluded.
• As the sample size would not be adequate to examine their risk separately, Tartars and Bashkirs will not be included in the study.
• The comparison population will be drawn from current and former workers in the auxiliary plants (water treatment facility and mechanical repair plant) at the Mayak facility.
• Included will be a stratified random sample of these workers who were employed from 1948-1972, who have remained local residents, and who have estimates of their external gamma dose.
• Individuals selected will be frequency-matched according to age (5 year age groups) and gender to the exposed worker population.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Southern Urals Biophysics Institute

Ozersk, Russia

Location

Related Publications (3)

• Bonassi S, Hagmar L, Stromberg U, Montagud AH, Tinnerberg H, Forni A, Heikkila P, Wanders S, Wilhardt P, Hansteen IL, Knudsen LE, Norppa H. Chromosomal aberrations in lymphocytes predict human cancer independently of exposure to carcinogens. European Study Group on Cytogenetic Biomarkers and Health. Cancer Res. 2000 Mar 15;60(6):1619-25.

  PMID: 10749131 BACKGROUND

• Cardis E, Gilbert ES, Carpenter L, Howe G, Kato I, Armstrong BK, Beral V, Cowper G, Douglas A, Fix J, et al. Effects of low doses and low dose rates of external ionizing radiation: cancer mortality among nuclear industry workers in three countries. Radiat Res. 1995 May;142(2):117-32.

  PMID: 7724726 BACKGROUND

• Dupont WD, Plummer WD Jr. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998 Dec;19(6):589-601. doi: 10.1016/s0197-2456(98)00037-3.

  PMID: 9875838 BACKGROUND

Study Officials

• Martha Linet, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 1, 2007
• First Posted: June 4, 2007
• Study Start: June 9, 2004
• Study Completion: September 17, 2014
• Last Updated: December 17, 2019

Record last verified: 2014-09-17

Locations

RU (1)