Frequency of Chromosome AberrationsNCT00341900
Study of Markers of Cosmic Radiation Exposure and Effect Among Flight Crews
An observational study of Frequency of Chromosome Aberrations, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men only
- Conditions the study is for
- Frequency of Chromosome Aberrations
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2001to 3 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Pilots estimated to have high comic radiation exposure based on flight histories.
Who may be able to join
- PILOTS:
- Subjects will be Chicago based pilots who fly international flights out of Chicago.
- Subjects must have worked at least 10 years as an international pilot.
- EXTERNAL COMPARISON GROUP:
- Subjects must be currently employed as university faculty from the Chicago area.
- Pilots and External Comparison Group Subjects:
Show all 9Show fewer
- Age 35-54.
- Non-Smoker (less than 100 lifetime cigarettes).
- Male.
Who cannot join
- PILOTS AND EXTERNAL COMPARISON GROUP SUBJECTS:
- No personal history of cancer.
- No history of chemotherapy.
- No history of major diagnostic radiation therapy (e.g., radio-imaging that exposed the large bones or lymph nodes except for routine medical and dental x-rays).
- No family history of hereditary diseases (ataxia telangiectasia, Fanconi's anemia, Bloom's syndrome, and xeroderma pigmentosum).
- EXTERNAL COMPARISON GROUP SUBJECTS:
Show all 9Show fewer
- Must not have a history of excessive past air travel (defined as no more than an average of one international flight/year and one domestic flight/month).
- No history of major illnesses, such as heart disease and diabetes.
- Must not have been employed in a clinical or laboratory area that involves exposure to radiation and chemotherapeutic drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute for Occupational Safety and Health
Cincinnati, Ohio, 26505-2888
About this study
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.
Read the detailed 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.
- Conditions
- Frequency of Chromosome Aberrations
- Keywords
- Chromosome Translocations, Cosmic Radiation, Airline Flight Crew, Airlines, Flight Crew, Occupational Exposure
- Medical subject headings
- Translocation, Genetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Male pilots with high cosmic radiation exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chromosome translocation frequency
Chromosome translocation frequency
Measured: One time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start9 Nov 2001
- Primary completion31 Dec 2016
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Frequency of Chromosome AberrationsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Sponsor
- Investigators
- Mark P Little, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341900
- Sponsor's protocol ID
- 999902043
- Other IDs
- 02-C-N043
- Status last verified
- Apr 2020
- First submitted
- 19 Jun 2006
- Last updated
- 7 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yong LC, Sigurdson AJ, Ward EM, Waters MA, Whelan EA, Petersen MR, Bhatti P, Ramsey MJ, Ron E, Tucker JD. Increased frequency of chromosome translocations in airline pilots with long-term flying experience. Occup Environ Med. 2009 Jan;66(1):56-62. doi: 10.1136/oem.2008.038901. Epub 2008 Dec 11.
PubMed 19074211Grajewski B, Waters MA, Yong LC, Tseng CY, Zivkovich Z, Cassinelli RT 2nd. Airline pilot cosmic radiation and circadian disruption exposure assessment from logbooks and company records. Ann Occup Hyg. 2011 Jun;55(5):465-75. doi: 10.1093/annhyg/mer024. Epub 2011 May 24.
PubMed 21610083Yong LC, Petersen MR, Sigurdson AJ, Sampson LA, Ward EM. High dietary antioxidant intakes are associated with decreased chromosome translocation frequency in airline pilots. Am J Clin Nutr. 2009 Nov;90(5):1402-10. doi: 10.3945/ajcn.2009.28207. Epub 2009 Sep 30.
PubMed 19793852
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Markers of Cosmic Radiation Exposure and Effect Among Flight Crews
- ClinicalTrials.gov ID
- NCT00341900
- Acronym / sponsor ID
- 999902043
- Conditions
- Frequency of Chromosome Aberrations
- Keywords
- Chromosome Translocations, Cosmic Radiation, Airline Flight Crew, Airlines, Flight Crew, Occupational Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- 9 Nov 2001 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Male pilots with high cosmic radiation exposure |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pilots estimated to have high comic radiation exposure based on flight histories.
Key inclusion criteria (9 listed)
- Subjects will be Chicago based pilots who fly international flights out of Chicago.
- Subjects must have worked at least 10 years as an international pilot.
- Subjects must be currently employed as university faculty from the Chicago area.
- Age 35-54.
- Non-Smoker (less than 100 lifetime cigarettes).
Key exclusion criteria (9 listed)
- No personal history of cancer.
- No history of chemotherapy.
- No history of major diagnostic radiation therapy (e.g., radio-imaging that exposed the large bones or lymph nodes except for routine medical and dental x-rays).
- No family history of hereditary diseases (ataxia telangiectasia, Fanconi's anemia, Bloom's syndrome, and xeroderma pigmentosum).
- Must not have a history of excessive past air travel (defined as no more than an average of one international flight/year and one domestic flight/month).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chromosome translocation frequency
Time frame: One time point
Chromosome translocation frequency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Background: PubMed 19074211Yong LC, Sigurdson AJ, Ward EM, Waters MA, Whelan EA, Petersen MR, Bhatti P, Ramsey MJ, Ron E, Tucker JD. Increased frequency of chromosome translocations in airline pilots with long-term flying experience. Occup Environ Med. 2009 Jan;66(1):56-62. doi: 10.1136/oem.2008.038901. Epub 2008 Dec 11.
- Background: PubMed 21610083Grajewski B, Waters MA, Yong LC, Tseng CY, Zivkovich Z, Cassinelli RT 2nd. Airline pilot cosmic radiation and circadian disruption exposure assessment from logbooks and company records. Ann Occup Hyg. 2011 Jun;55(5):465-75. doi: 10.1093/annhyg/mer024. Epub 2011 May 24.
- Background: PubMed 19793852Yong LC, Petersen MR, Sigurdson AJ, Sampson LA, Ward EM. High dietary antioxidant intakes are associated with decreased chromosome translocation frequency in airline pilots. Am J Clin Nutr. 2009 Nov;90(5):1402-10. doi: 10.3945/ajcn.2009.28207. Epub 2009 Sep 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark P Little, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frequency of Chromosome Aberrations, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chromosome translocation frequency (time frame: One time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341900, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.