COLONPREV
Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
N = 57,404NCT00906997
- Population
- Presumptively healthy people aged 50 to 69 at average risk for colorectal cancer; 57,404 randomized; the intention-to-screen population was 26,332 (colonoscopy) and 26,719 (FIT).
- Design
- Pragmatic, randomized, controlled, non-inferiority trial at 15 tertiary hospitals across eight regions of Spain. Presumptively healthy people aged 50 to 69 without a personal history of colorectal cancer, adenoma or inflammatory bowel disease, family history of hereditary or familial colorectal cancer, severe comorbidity or previous colectomy were randomly assigned 1:1 before invitation to one-time colonoscopy or biennial FIT. 57,404 were randomized between June 2009 and December 2021. Primary endpoint: colorectal cancer mortality at 10 years in the intention-to-screen population (26,332 colonoscopy; 26,719 FIT); non-inferiority required an absolute difference of less than 0.16 percentage points.
- Primary endpoint
- Colorectal cancer mortality
- Arms
- Invitation to colonoscopy (control, n = 28,708): Invitation to one-time colonoscopy
- Invitation to FIT (experimental, n = 28,696): Invitation to biennial fecal immunochemical test
- People
- Castells A
Δ Colorectal cancer mortality+0.02 pointsΔ Participation in screening+8.1 pointsΔ Participation in screening+9.6 points
Show the numbers
| Endpoint | Analysis | Invitation to FIT | Invitation to colonoscopy | Effect |
|---|---|---|---|---|
| Colorectal cancer mortalityIntention-to-screen population (26,332 colonoscopy; 26,719 FIT)Risk of death from colorectal cancer at 10 years | primaryCastells 2025 | 0.24% | 0.22% | P=0.0005 (non-inferiority)10-year risk; 55 vs 60 deaths. Risk difference -0.02 percentage points (95% CI -0.10 to 0.06) and risk ratio 0.92 (95% CI 0.64 to 1.32) are for colonoscopy relative to FIT (Table 1 of the accepted author manuscript, column 'Colonoscopy vs. FIT'; the abstract prints the values without labelling the direction). The risks are Kaplan-Meier cumulative estimates. Non-inferiority margin: an absolute difference of less than 0.16 percentage points. Risk ratio, not a hazard ratio. Both arms are screening strategies; there is no unscreened comparison. |
| Participation in screeningIntention-to-screen population (26,332 colonoscopy; 26,719 FIT)Participation in any form of screening in the intention-to-screen population | primaryCastells 2025 | 39.9% | 31.8% | Risk ratio 0.79 (95% CI 0.77 to 0.82) for colonoscopy relative to FIT, as printed (31.8/39.9). Participation counts any form of screening: in the colonoscopy group 5,293 people had the assigned colonoscopy and 3,074 had FIT; in the FIT group 10,525 had FIT and 126 had colonoscopy (accepted author manuscript). |
| Participation in screeningRandomized participants at completion of baseline screening (26,703 colonoscopy; 26,599 FIT)Rate of participation at the baseline screening examination (interim report) | interimQuintero 2012 | 34.2% | 24.6% | P<0.001Interim report at completion of baseline screening; mortality is not reported in this paper. Participation differs from the 2025 report because the populations and definitions differ. |
| Endpoint | Analysis | Invitation to FIT | Invitation to colonoscopy | Effect |
|---|---|---|---|---|
| Colorectal cancer mortalityIntention-to-screen population (26,332 colonoscopy; 26,719 FIT)Risk of death from colorectal cancer at 10 years | primaryCastells 2025 | 0.24% | 0.22% | P=0.0005 (non-inferiority)10-year risk; 55 vs 60 deaths. Risk difference -0.02 percentage points (95% CI -0.10 to 0.06) and risk ratio 0.92 (95% CI 0.64 to 1.32) are for colonoscopy relative to FIT (Table 1 of the accepted author manuscript, column 'Colonoscopy vs. FIT'; the abstract prints the values without labelling the direction). The risks are Kaplan-Meier cumulative estimates. Non-inferiority margin: an absolute difference of less than 0.16 percentage points. Risk ratio, not a hazard ratio. Both arms are screening strategies; there is no unscreened comparison. |
| Participation in screeningIntention-to-screen population (26,332 colonoscopy; 26,719 FIT)Participation in any form of screening in the intention-to-screen population | primaryCastells 2025 | 39.9% | 31.8% | Risk ratio 0.79 (95% CI 0.77 to 0.82) for colonoscopy relative to FIT, as printed (31.8/39.9). Participation counts any form of screening: in the colonoscopy group 5,293 people had the assigned colonoscopy and 3,074 had FIT; in the FIT group 10,525 had FIT and 126 had colonoscopy (accepted author manuscript). |
| Participation in screeningRandomized participants at completion of baseline screening (26,703 colonoscopy; 26,599 FIT)Rate of participation at the baseline screening examination (interim report) | interimQuintero 2012 | 34.2% | 24.6% | P<0.001Interim report at completion of baseline screening; mortality is not reported in this paper. Participation differs from the 2025 report because the populations and definitions differ. |
Appears in
Sources
Castells A, Quintero E, Bujanda L, Castán-Cameo S, Cubiella J, Díaz-Tasende J, et al. Effect of invitation to colonoscopy versus faecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial. Lancet. 2025;405(10486):1231-1239.
Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas Á, et al. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012;366(8):697-706.