COLONPREV
Trial question
Is fecal immunochemical testing noninferior to colonoscopy for CRC screening in average-risk adults?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 53302
53302 patients (28729 female, 24573 male).
Inclusion criteria: asymptomatic adults 50 to 69 years of age.
Key exclusion criteria: personal history of CRC, adenoma, or IBD, a family history of hereditary or familial CRC, a severe coexisting illness, and previous colectomy.
Interventions
N=26599 fecal immunochemical testing (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 %
0.0 %
0.0 %
Fecal immunochemical
testing
Colonoscopy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in CRC (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, fecal immunochemical testing was noninferior to colonoscopy with respect to CRC.
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.
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