This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.
This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel among subjects with a recent history of these tumors. The study is a randomized, double-blind, placebo-controlled trial with a 2 x 3 factorial design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,121
USC/Kaiser
Los Angeles, California, United States
University of Colorado
Denver, Colorado, United States
University of Iowa
Iowa City, Iowa, United States
Henry Ford Health Sciences Center
Detroit, Michigan, United States
1 or more adenomas
colorectal adenomas detected at follow-up colonoscopy
Time frame: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
number of adenomas
colorectal adenomas detected at follow-up colonoscopy
Time frame: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
1 or more advanced lesions
adenomas measuring at least 1 cm in diameter or with tubulovillous or villous features, severe dysplasia, or invasive cancer
Time frame: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
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University of Minnesota
Minneapolis, Minnesota, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Toronto
Toronto, Ontario, Canada