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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00342407
Other study ID # 999902039
Secondary ID 02-C-N039
Status Completed
Phase
First received
Last updated
Start date November 6, 2001
Est. completion date April 9, 2020

Study information

Verified date April 2020
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6093
Est. completion date April 9, 2020
Est. primary completion date December 31, 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 100 Years
Eligibility - INCLUSION CRITERIA:

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.

Study Design


Locations

Country Name City State
United States National Institute for Occupational Safety and Health (NIOSH) Cincinnati Ohio

Sponsors (3)

Lead Sponsor Collaborator
National Cancer Institute (NCI) Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Pinkerton 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. — View Citation

Waters 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Breast and other cancers survival Time of questionnaire, time of death
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