Thyroid CancerNCT00342407
The Incidence of Breast and Other Cancers Among Female Flight Attendants
An observational study of Thyroid Cancer and Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Flight attendants may be at an increased risk of breast and other cancers due to work-place exposures including cosmic radiation and circadian rhythm disruption form traveling across multiple time zones. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer, Breast Cancer, Non-Melanoma Skin Cancer
- How many people
- 6,093 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2001to 9 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 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female flight attendants
Who may be able to join
- Employed as a flight attendant for one or more years by Pan AM before Pan Am ceased operation in 1991. For flight attendants who transferred to Pan Am from National Airlines when Pan Am bought National Airlines in 1981, the time employed as a flight attendant at National Airlines will be counted towards the one year minimum.
- A U.S. citizen when they began working at Pan Am (or National Airlines, if the flight attendant transferred to Pan AM from National Airlines).
- Worked at least one day after January 1, 1953.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute for Occupational Safety and Health (NIOSH)
Cincinnati, Ohio, 45226
About this study
Flight attendants may be at an increased risk of breast and other cancers due to work-place exposures including cosmic radiation and circadian rhythm disruption form traveling across multiple time zones. This cancer incidence study will determine whether female flight attendants are at increased risk of breast and other cancers and whether the risk is dose-related. The study will include a cohort of approximately 10,000 women who were employed as flight attendants for one or more years.
Breast cancer cases will be identified from telephone interviews of living subjects and next-of-kin of deceased subjects, as well as from death certificates. The interview will also provide information about non-occupational risk factors for breast cancer such as parity. Both internal and external comparisons will be made. The primary analysis will evaluate the risk associated with occupational exposure within the cohort, controlling for non-occupational risk factors by stratification or modeling. The secondary analysis will compare the incidence of breast cancer in the cohort to that in the general population, with adjustment for factors such as lower parity which might increase breast cancer risk in the cohort independent of occupational exposure to cosmic radiation and circadian rhythm disruption. The risk of other ionizing radiation-related cancers, such as leukemia, lung cancer, and thyroid cancer, among flight attendants will also be evaluated. The results of the study will apply to female flight crew and frequent fliers.
Read the detailed description
Flight attendants may be at an increased risk of breast and other cancers due to work-place exposures including cosmic radiation and circadian rhythm disruption from traveling across multiple time zones. This cancer incidence study will determine whether female flight attendants are at increased risk of breast and other cancers and whether the risk is dose-related. The study will include a cohort of approximately 9,631 women who were employed as flight attendants for one or more years.
Breast cancer cases will be identified from telephone interviews of living subjects and next-of-kin of deceased subjects, as well as from death certificates. The interview will also provide information about non-occupational risk factors for breast cancer such as parity. Both internal and external comparisons will be made. The primary analysis will evaluate the risk associated with occupational exposure within the cohort, controlling for non-occupational risk factors by stratification or modeling. The secondary analysis will compare the incidence of breast cancer in the cohort to that in the general population, with adjustment for factors such as lower parity which might increase breast cancer risk in the cohort independent of occupational exposure to cosmic radiation and circadian rhythm disruption. The risk of other ionizing radiation-related cancers, such as leukemia, lung cancer, and thyroid cancer, among flight attendants will also be evaluated. The results of the study will apply to female flight crew and frequent fliers.
- Conditions
- Thyroid Cancer, Breast Cancer, Non-Melanoma Skin Cancer, Melanoma
- Keywords
- Cancer Risk, Cosmic Radiation, Airlines, Flight Attendants, Circadian Rhythm
- Medical subject headings
- Thyroid Neoplasms, Breast Neoplasms, Melanoma
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 |
|---|---|---|
| Cohort | Female flight attendants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast and other cancers
survival
Measured: Time of questionnaire, time of death
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 start6 Nov 2001
- Primary completion31 Dec 2005
- Study completion9 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 Thyroid CancerStudies 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
- Other
- Enrolment
- 6,093 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
- NCT00342407
- Sponsor's protocol ID
- 999902039
- Other IDs
- 02-C-N039
- Status last verified
- Apr 2020
- First submitted
- 19 Jun 2006
- Last updated
- 10 Apr 2020
- Results posted
- No
Publications
Grajewski B, Waters MA, Whelan EA, Bloom TF. Radiation dose estimation for epidemiologic studies of flight attendants. Am J Ind Med. 2002 Jan;41(1):27-37. doi: 10.1002/ajim.10018.
PubMed 11757053Pinkerton LE, Waters MA, Hein MJ, Zivkovich Z, Schubauer-Berigan MK, Grajewski B. Cause-specific mortality among a cohort of U.S. flight attendants. Am J Ind Med. 2012 Jan;55(1):25-36. doi: 10.1002/ajim.21011. Epub 2011 Oct 10.
PubMed 21987391Waters MA, Grajewski B, Pinkerton LE, Hein MJ, Zivkovich Z. Development of historical exposure estimates of cosmic radiation and circadian rhythm disruption for cohort studies of Pan Am flight attendants. Am J Ind Med. 2009 Oct;52(10):751-61. doi: 10.1002/ajim.20738.
PubMed 19722196
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Breast and Other Cancers Among Female Flight Attendants
- ClinicalTrials.gov ID
- NCT00342407
- Acronym / sponsor ID
- 999902039
- Conditions
- Thyroid Cancer, Breast Cancer, Non-Melanoma Skin Cancer, Melanoma
- Keywords
- Cancer Risk, Cosmic Radiation, Airlines, Flight Attendants, Circadian Rhythm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,093 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
- 6 Nov 2001 (actual)
- Primary completion
- 31 Dec 2005 (actual)
- Study completion
- 9 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.
Flight attendants may be at an increased risk of breast and other cancers due to work-place exposures including cosmic radiation and circadian rhythm disruption form traveling across multiple time zones. This cancer incidence study will determine whether female flight attendants are at increased risk of breast and other cancers and whether the risk is dose-related. The study will include a cohort of approximately 10,000 women who were employed as flight attendants for one or more years.
Breast cancer cases will be identified from telephone interviews of living subjects and next-of-kin of deceased subjects, as well as from death certificates. The interview will also provide information about non-occupational risk factors for breast cancer such as parity. Both internal and external comparisons will be made. The primary analysis will evaluate the risk associated with occupational exposure within the cohort, controlling for non-occupational risk factors by stratification or modeling. The secondary analysis will compare the incidence of breast cancer in the cohort to that in the general population, with adjustment for factors such as lower parity which might increase breast cancer risk in the cohort independent of occupational exposure to cosmic radiation and circadian rhythm disruption. The risk of other ionizing radiation-related cancers, such as leukemia, lung cancer, and thyroid cancer, among flight attendants will also be evaluated. The results of the study will apply to female flight crew and frequent fliers.
Detailed description
Flight attendants may be at an increased risk of breast and other cancers due to work-place exposures including cosmic radiation and circadian rhythm disruption from traveling across multiple time zones. This cancer incidence study will determine whether female flight attendants are at increased risk of breast and other cancers and whether the risk is dose-related. The study will include a cohort of approximately 9,631 women who were employed as flight attendants for one or more years.
Breast cancer cases will be identified from telephone interviews of living subjects and next-of-kin of deceased subjects, as well as from death certificates. The interview will also provide information about non-occupational risk factors for breast cancer such as parity. Both internal and external comparisons will be made. The primary analysis will evaluate the risk associated with occupational exposure within the cohort, controlling for non-occupational risk factors by stratification or modeling. The secondary analysis will compare the incidence of breast cancer in the cohort to that in the general population, with adjustment for factors such as lower parity which might increase breast cancer risk in the cohort independent of occupational exposure to cosmic radiation and circadian rhythm disruption. The risk of other ionizing radiation-related cancers, such as leukemia, lung cancer, and thyroid cancer, among flight attendants will also be evaluated. The results of the study will apply to female flight crew and frequent fliers.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Female flight attendants |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female flight attendants
Key inclusion criteria (3 listed)
- Employed as a flight attendant for one or more years by Pan AM before Pan Am ceased operation in 1991. For flight attendants who transferred to Pan Am from National Airlines when Pan Am bought National Airlines in 1981, the time employed as a flight attendant at National Airlines will be counted towards the one year minimum.
- A U.S. citizen when they began working at Pan Am (or National Airlines, if the flight attendant transferred to Pan AM from National Airlines).
- Worked at least one day after January 1, 1953.
Key exclusion criteria (0 listed)
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
Breast and other cancers
Time frame: Time of questionnaire, time of death
survival
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 10 Apr 2020.
- Background: PubMed 11757053Grajewski B, Waters MA, Whelan EA, Bloom TF. Radiation dose estimation for epidemiologic studies of flight attendants. Am J Ind Med. 2002 Jan;41(1):27-37. doi: 10.1002/ajim.10018.
- Background: PubMed 21987391Pinkerton LE, Waters MA, Hein MJ, Zivkovich Z, Schubauer-Berigan MK, Grajewski B. Cause-specific mortality among a cohort of U.S. flight attendants. Am J Ind Med. 2012 Jan;55(1):25-36. doi: 10.1002/ajim.21011. Epub 2011 Oct 10.
- Background: PubMed 19722196Waters MA, Grajewski B, Pinkerton LE, Hein MJ, Zivkovich Z. Development of historical exposure estimates of cosmic radiation and circadian rhythm disruption for cohort studies of Pan Am flight attendants. Am J Ind Med. 2009 Oct;52(10):751-61. doi: 10.1002/ajim.20738.
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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 Thyroid Cancer and Breast Cancer, 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 3 inclusion and 0 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 10 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?
Breast and other cancers (time frame: Time of questionnaire, time of death). 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 NCT00342407, 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 10 Apr 2020.