000153654 001__ 153654 000153654 005__ 20251017144558.0 000153654 0247_ $$2doi$$a10.1016/S0140-6736(25)00145-X 000153654 0248_ $$2sideral$$a143785 000153654 037__ $$aART-2025-143785 000153654 041__ $$aeng 000153654 100__ $$aCastells, Antoni 000153654 245__ $$aEffect of invitation to colonoscopy versus faecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial 000153654 260__ $$c2025 000153654 5203_ $$aBackground: Colonoscopy 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. Methods: COLONPREV 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. Findings: Between 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). Interpretation: Participation 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. 000153654 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII/CD22-00087$$9info:eu-repo/grantAgreement/ES/ISCIII/FI22-00203$$9info:eu-repo/grantAgreement/ES/ISCIII/INT22-00009$$9info:eu-repo/grantAgreement/ES/ISCIII/PI08-90717 000153654 540__ $$9info:eu-repo/semantics/closedAccess$$aAll rights reserved$$uhttp://www.europeana.eu/rights/rr-f/ 000153654 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000153654 700__ $$aQuintero, Enrique 000153654 700__ $$aBujanda, Luis 000153654 700__ $$aCastán-Cameo, Susana 000153654 700__ $$aCubiella, Joaquín 000153654 700__ $$aDíaz-Tasende, José 000153654 700__ $$0(orcid)0000-0001-5932-2889$$aLanas, Ángel$$uUniversidad de Zaragoza 000153654 700__ $$aAkiko, Ono 000153654 700__ $$aSerra-Burriel, Miquel 000153654 700__ $$aFrías-Arrocha, Eladio 000153654 700__ $$aHernández, Cristina 000153654 700__ $$aJover, Rodrigo 000153654 700__ $$aAndreu, Montserrat 000153654 700__ $$aCarballo, Fernando 000153654 700__ $$aMorillas, Juan Diego 000153654 700__ $$aSalas, Dolores 000153654 700__ $$aAlmazán, Raquel 000153654 700__ $$aAlonso-Abreu, Inmaculada 000153654 700__ $$aBanales, Jesús M. 000153654 700__ $$aHernández, Vicent 000153654 700__ $$aPortillo, Isabel 000153654 700__ $$aVanaclocha-Espí, Mercedes 000153654 700__ $$aVega, Mariola de la 000153654 700__ $$aCOLONPREV study investigators 000153654 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000153654 773__ $$g405, 10486 (2025), 1231-1239$$pLancet$$tThe Lancet$$x0140-6736 000153654 8564_ $$s868409$$uhttps://zaguan.unizar.es/record/153654/files/texto_completo.pdf$$yVersión publicada 000153654 8564_ $$s3102736$$uhttps://zaguan.unizar.es/record/153654/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000153654 909CO $$ooai:zaguan.unizar.es:153654$$particulos$$pdriver 000153654 951__ $$a2025-10-17-14:13:41 000153654 980__ $$aARTICLE