Clinical trial · Interventional
Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aims: 1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population. 2. To determine the compliance and complications associated with both strategies. Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia). Study groups: * Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result. * Group II: colonoscopy. Sample-size calculation: 27,749 subjects in each study group (total: 55,498).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Procedure | — | UNRESOLVED |
| Immunochemical fecal occult blood test | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fecal occult blood testing
- description
- Fecal immunochemical testing biennially
- interventionNames
- Procedure: Immunochemical fecal occult blood test
- type
- ACTIVE_COMPARATOR
- label
- Colonoscopy
- description
- Colonoscopy one time
- interventionNames
- Procedure: Colonoscopy
Primary outcomes (1)
- measure
- Colorectal cancer-related mortality
- timeFrame
- 10 years
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women aged 50-69 years Exclusion Criteria: * Personal history of colorectal cancer, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease * Family history of colorectal polyposis, Lynch syndrome or familial colorectal cancer (2 or more first-degree relatives diagnosed with colorectal cancer or one first-degree relative diagnosed with colorectal cancer before the age of 60) * Severe comorbidity * Previous total colectomy * Not signed informed consent to participate
References
Publications (10)
- DERIVEDCubiella J, Garcia-Benito C, Castells A, Quintero E, Bujanda L, Castan-Cameo S, Diaz-Tasende J, Lanas A, Ono A, Frias-Arrocha E, Hernandez C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D, Regueiro-Exposito C, Davila-Pinon P, Diez-Martin A; COLONPREV study investigators. Long-Term Colorectal Cancer Incidence After Adenoma and Serrated Polyp Removal: Results From the Colonprev Trial. United European Gastroenterol J. 2026 Jun;14(5):e70245. doi: 10.1002/ueg2.70245. PMID 42272346
- DERIVEDCastells A, Quintero E, Chen H, Bujanda L, Castan-Cameo S, Cubiella J, Diaz-Tasende J, Lanas A, Ono A, Serra-Burriel M; COLONPREV Study Investigators. Colonoscopy versus biennial FIT screening: a post hoc sustained-strategy analysis of the COLONPREV Trial. Gut. 2026 Jun 10:gutjnl-2026-338896. doi: 10.1136/gutjnl-2026-338896. Online ahead of print. PMID 42270316
- DERIVEDCastells A, Quintero E, Serra-Burriel M, Bujanda L, Castan-Cameo S, Cubiella J, Diaz-Tasende J, Lanas A, Ono A, Coll-Vinent B, Frias-Arrocha E, Hernandez C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D; COLONPREV study investigators. Sex- and Age-Stratified Outcomes of Colonoscopy Versus Faecal Immunochemical Testing: Post-Analysis of the COLONPREV Study. United European Gastroenterol J. 2026 Mar;14(2):e70169. doi: 10.1002/ueg2.70169. PMID 41715250
- DERIVEDCastells A, Quintero E, Bujanda L, Castan-Cameo S, Cubiella J, Diaz-Tasende J, Lanas A, Ono A, Serra-Burriel M, Frias-Arrocha E, Hernandez C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D, Almazan R, Alonso-Abreu I, Banales JM, Hernandez V, Portillo I, Vanaclocha-Espi M, de la Vega M; COLONPREV study investigators. Effect of invitation to colonoscopy versus faecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial. Lancet. 2025 Apr 12;405(10486):1231-1239. doi: 10.1016/S0140-6736(25)00145-X. Epub 2025 Mar 27. PMID 40158525
- DERIVEDShaukat A, Kahi CJ, Burke CA, Rabeneck L, Sauer BG, Rex DK. ACG Clinical Guidelines: Colorectal Cancer Screening 2021. Am J Gastroenterol. 2021 Mar 1;116(3):458-479. doi: 10.14309/ajg.0000000000001122.