RT Journal Article
T1 Effect of invitation to colonoscopy versus faecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial
A1 Castells, A.
A1 Díaz Tasende, José Benjamín
A1 Marín Gabriel, José Carlos
AB BackgroundColonoscopy and the faecal immunochemical test are accepted strategies for colorectal cancer screening in the average-risk population (ie, people aged ≥50 years without personal or family history of colorectal cancer). In this trial, we aimed to compare whether invitation to screening with faecal immunochemical test was non-inferior to colonoscopy in a screening programme.MethodsCOLONPREV was a pragmatic, randomised, controlled, non-inferiority trial done at 15 tertiary hospitals across eight regions of Spain. Eligible participants were presumptively healthy and aged between 50 years and 69 years without a personal history of colorectal cancer, adenoma or inflammatory bowel disease, family history of hereditary or familial colorectal cancer (ie, two or more first-degree relatives with colorectal cancer or one diagnosed before age 60 years), severe comorbidities, or previous colectomy. Participants were randomly assigned (1:1) to one-time colonoscopy or biennial faecal immunochemical test before invitation to screening. The primary endpoint was colorectal cancer mortality at 10 years, assessed in the intention-to-screen population. An absolute difference of less than 0·16 percentage points was required to show non-inferiority. This trial was registered with ClinicalTrials.gov, NCT00906997.FindingsBetween June 1, 2009, and Dec 31, 2021, 57 404 individuals were randomly assigned to receive an invitation for colonoscopy (n=28 708) or the faecal immunochemical test (n=28 696). The intention-to-screen population consisted of 26 332 individuals in the colonoscopy group and 26 719 in the faecal immunochemical test group. In the intention-to-screen population, participation in any form of screening was 31·8% in the colonoscopy group and 39·9% in the faecal immunochemical test group (risk ratio [RR] 0·79 [95% CI 0·77 to 0·82]). Faecal immunochemical testing was non-inferior to colonoscopy with regard to the risk of colorectal cancer mortality at 10 years: the risk was 0·22% (55 deaths) in the colonoscopy group and 0·24% (60 deaths) in the faecal immunochemical test group (risk difference –0·02 [95% CI –0·10 to 0·06; RR 0·92 [95% CI 0·64 to 1·32]; pnon-inferiority=0·0005).InterpretationParticipation in screening was higher among individuals invited to faecal immunochemical test screening than colonoscopy screening. On the basis of participation observed in this study, a faecal immunochemical test-based programme was non-inferior to a colonoscopy-based programme for colorectal cancer-related mortality.
PB Elsevier
YR 2025
FD 2025
LK https://hdl.handle.net/20.500.14352/130620
UL https://hdl.handle.net/20.500.14352/130620
LA eng
NO 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. The Lancet 2025;405:1231–9. https://doi.org/10.1016/S0140-6736(25)00145-X.
DS Docta Complutense
RD 27 feb 2026