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Clinical Trial Summary

Ionizing radiation efficiently induces chromosomal aberrations (CA) and several studies of CA have now been conducted among small groups of flight crews. However, most of the studies only evaluated the unstable aberrations that reflect recent exposures, but not long-term cumulative cosmic radiation exposure. Chromosome painting by fluorescence in situ hybridization (FISH) is a widely used and established cytogenetic method for detecting stable aberrations such as translocations. Thus, FISH can be used for estimating chromosomal damage from cumulative radiation exposure. No large studies of flight crews utilizing FISH have been conducted to date.

We propose a study to measure CA using FISH in a group of pilots estimated to have high comic radiation exposure based on flight histories, i.e., those with long duration flying international routes, and a comparison group of university faculty with minimal flying history. These measurements will be used to determine if pilots have elevated frequencies of CA (specifically stable translocations) as compared with the university faculty. In addition, the frequencies of CA will be examined in relation to the cumulative cosmic radiation dose to determine if there is a dose-response relationship. Individual cumulative doses will be calculated from pilot flight histories using a computer program developed by the FAA which estimates cosmic radiation does by accounting for changes in altitude and latitude, and the 11-year solar cycle at the time of the flight. We will collect information on age, lifestyle factors, diet, health history, family cancer history, and medical radiation exposures from personal interview and self-administered dietary questionaire. These factors may affect the CA frequency and so we plan to adjust for them in the statistical analyses.

Pilots will be identified based on the Allied Pilots Association roster and faculty from a commercial company that maintains a database of university faculty, including those in the Chicago area. Potential participants will be notified of the study by mail and recruited/screened for eligibility over the telephone. We will compensate participants $100 for their time. A field station will be set up at a medical or health clinic convenient to the participants, where interviews Will be conducted and a peripheral blood sample collected. Participants will be notified of the overall study results and may request their personal CA results at the end of the study. Participants may also choose to have additional blood drawn, however this blood sample will be anonymized so that it cannot be linked back to the participant. Genotypic variants in DNA repair (and possibly other) genes will be evaluated for an effect on CA frequency.


Clinical Trial Description

Ionizing radiation efficiently induces chromosomal aberrations (CA) and several studies of CA have now been conducted among small groups of flight crews. However, most of the studies only evaluated the unstable aberrations that reflect recent exposures, but not long-term cumulative cosmic radiation exposure. Chromosome painting by fluorescence in situ hybridization (FISH) is a widely used and established cytogenetic method for detecting stable aberrations such as translocations. Thus, FISH can be used for estimating chromosomal damage from cumulative radiation exposure. No large studies of flight crews utilizing FISH have been conducted to date.

In collaboration with the National Institute for Occupational Safety and Health (NIOSH), we proposed a study to measure CA using FISH in a group of pilots estimated to have high comic radiation exposure based on flight histories, i.e., those with long duration flying international routes, and a comparison group of university faculty with minimal flying history. These measurements will be used to determine if pilots have elevated frequencies of CA (specifically stable translocations) as compared with the university faculty. In addition, the frequencies of CA will be examined in relation to the cumulative cosmic radiation dose to determine if there is a dose-response relationship. Individual cumulative doses will be calculated from pilot flight histories using a computer program developed by the FAA which estimates cosmic radiation does by accounting for changes in altitude and latitude, and the 11-year solar cycle at the time of the flight. We will collect information on age, lifestyle factors, diet, health history, family cancer history, and medical radiation exposures from a self-administered study and dietary questionnaire. These factors may affect the CA frequency and so we plan to adjust for them in the statistical analyses.

Pilots were identified based on the Allied Pilots Association roster and faculty from a commercial company that maintains a database of university faculty, including those in the Chicago area. Potential participants will be notified of the study by mail and recruited/screened for eligibility over the telephone. We compensated participants $100 for their time and inconvenience. Two field stations were arranged at the O'Hare UIC medical clinic for pilots and at the UIC Health Services clinic (on campus) for the faculty, where interviews were conducted and a peripheral blood sample collected. Participants will be notified of the overall study results and may request their personal CA results at the end of the study. Participants may also choose to have additional blood drawn, however this blood sample will be anonymized so that it cannot be linked back to the participant. Genotypic variants in DNA repair (and possibly other) genes will be evaluated for an effect on CA frequency. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00341900
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase
Start date November 9, 2001
Completion date April 3, 2020