Learn About the Minnesota Colon Cancer Control Study
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.
Schema Description
Healthy volunteers are randomized into one of three arms with screening lasting up to 12 years. The first arm, called the annual arm gets yearly blood hemoccult cultures. The second arm, the biennial arm, gets hemoccult cultures taken every 2 years. The last arm is the control arm in which patients receive their usual medical care. After the main portion of the trial ended, there was annual questionnaire follow-up as well as periodic checking of death certificates and other relevant medical records.
The study had roughly 46,500 participants split between the control and two intervention arms. The intervention arms were asked to submit hemoccult slides either annually or biennially depending on arm. The participants were not to eat red meat, fish, poultry, certain fruits and vegetables, vitamin C tables, and aspirin for 24 hours before sample collection. Slides were mailed to and then tested by the laboratories at the University of Minnesota Hospital. Participants were notified of screening results and those with positive slides were asked to return to the hospital for an examination. The examination consisted of a history and physical examination, rigid proctosigmoidoscopy, single-column barium enema radiography, complete blood count, urinalysis, routine tests of blood chemistry, upper gastrointestinal series, chest radiography, electrocardiography, and a colonoscopy. The single-column barium-enema radiography was switched to a double-contrast barium enema and the proctosigmoidoscopy and upper gastrointestinal series were stopped in 1982. Along with annual questionnaires to all three arms, death certificates were also obtained and reviewed.