Summary
The Mayo Lung Project was a two arm randomized screening study designed to test if lung cancer mortality rates could be reduced through the use of periodic screenings. The intervention arm was offered a chest x-ray and sputum cytology every four months for six years while the usual care arm was advised at trial entry to receive the same tests annually. Extended follow-up was conducted through 1996. The study concluded that there was not a lung cancer mortality reduction for the intervention arm.
Study Years: 1971-1983
Randomized trial with two arms:
- Arm I: Usual Care
- Arm II: Intervention Screening (chest x-ray and sputum cytology)
Study Eligibility:
- Ages Eligible for Study: 45-80
- Sexes Eligible for Study: Male
- Recruited from Mayo Clinic outpatients
- Without known lung cancer
- Smokers of at least one pack of cigarettes per day
- Expected life expectancy of 5 or more years
- Respiratory reserve adequate to undergo lobectomy
Enrollment
Enrollment: 11,100
- 5,617 in Intervention Arm
- 5,483 in Control Arm
Total Study Population Demographics (11,100 Randomized and Eligible People):
- Age (years):
- Mean: 55.4
- Range: 38-76
- Median: 55
Schema
The Schema is a timeline of the study. It indicates start/end points, visits expected, major testing to be done, and any other information that is crucial to understanding how the study was completed.
Mayo Clinic outpatients were considered for this trial and went through an initial referral, interview, questionnaire, and signing an informed consent form before being randomized. The trial lasted for 6 years. After randomization, participants received a prevalence screen, PA & lateral chest x-ray, and a 3-day spontaneous sputum cytology. The control arm of the study was advised to receive annual chest x-rays and sputum cytology as well as receiving an annual questionnaire. The intervention arm was provided PA & lateral chest x-rays and 3-day spontaneous sputum cytology every 4 months until trial end.
