6/28/23, 12:14 AM COLONPREV Pathway Feedback Search Clinical Topics Home Studies COLONPREV COLONPREV Disease Disease Colon cancer Rectal cancer Trial question Is FITing noninferior to colonoscopy for colorectal cancer screening in average-risk adults? Study design Multi-center Open label RCT Population Characteristics of study participants 53.8% female N = 57404 46.2% male 57404 patients (28729 female, 24573 male) Inclusion criteria: asymptomatic adults 50 to 69 years of age Key exclusion criteria: personal history of colorectal cancer, adenoma, or IBD, a family history of hereditary or familial colorectal cancer, a severe coexisting illness, and previous colectomy Interventions N=26599 FITing (single stool sample every 2 years) N=26703 colonoscopy (one-time colonoscopy with bowel cleansing and sedation) Primary outcome Colorectal cancer 0.1 % 0.1 0.1 0.1 % 0.1 % https://web.pathway.md/studies/reco84XJPr74Rtfkc 1/2 6/28/23, 12:14 AM COLONPREV Pathway Difference not exceeding nonferiority margin 0.0 % 0.0 % Fecal immunochemical testing Colonoscopy Difference not exceeding nonferiority margin in colorectal cancer (0.1% vs. 0.1%; OR 0.99, 99% CI 0.61 to 1.64) Secondary outcomes Significant increase in advanced adenomas (0.9% vs. 1.9%; OR 2.3, 95% CI 1.97 to 2.69) Significant increase in nonadvanced adenomas (0.4% vs. 4.2%; OR 9.8, 95% CI 8.1 to 11.85) Significant decrease in participation (34.2% vs. 24.6%; OR 0.63, 95% CI 0.6 to 0.65) Safety outcomes Significant difference in major complications (0.1% vs. 0.5%). Conclusion In asymptomatic adults 50 to 69 years of age, FITing was noninferior to colonoscopy with respect to colorectal cancer. Reference Quintero E, Castells A, Bujanda L et al. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. Open reference URL https://web.pathway.md/studies/reco84XJPr74Rtfkc 2/2