Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

Conditions

Colorectal Cancer, Colorectal Neoplasm

Keywords

Colorectal cancer, Screening, Prevention, Fecal occult blood test, Colonoscopy, Colorectal neoplasm, Randomized clinical trial

Brief summary

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).

Antoni Castells, Enrique Quintero, Hongruyu Chen, Luis Bujanda, Susana Castán Cameo et al. (10 authors)

Gut2026-06-10

10.1136/gutjnl-2026-338896

Sex- and Age-Stratified Outcomes of Colonoscopy Versus Faecal Immunochemical Testing: Post-Analysis of the COLONPREV Study.

Castells A, Quintero E, Serra-Burriel M, Bujanda L, Castán-Cameo S, Cubiella J, Díaz-Tasende J, Lanas Á, Ono A, Coll-Vinent B, Frías-Arrocha E, Hernández C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D, COLONPREV study investigators.

2026-03-01

10.1002/ueg2.70169

Effect of invitation to colonoscopy versus faecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial.

Castells A, Quintero E, Bujanda L, Castán-Cameo S, Cubiella J, Díaz-Tasende J, Lanas Á, Ono A, Serra-Burriel M, Frías-Arrocha E, Hernández C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D, Almazán R, Alonso-Abreu I, Banales JM, Hernández V, Portillo I, Vanaclocha-Espí M, de la Vega M, COLONPREV study investigators.

2025-03-2719 citations

10.1016/s0140-6736(25)00145-x

Correlation between adenoma detection rate in colonoscopy- and fecal immunochemical testing-based colorectal cancer screening programs.

Cubiella J, Castells A, Andreu M, Bujanda L, Carballo F, Jover R, Lanas Á, Morillas JD, Salas D, Quintero E, COLONPREV study investigators.

2016-07-2040 citations

10.1177/2050640616660662

Rate of detection of advanced neoplasms in proximal colon by simulated sigmoidoscopy vs fecal immunochemical tests.

Castells A, Quintero E, Álvarez C, Bujanda L, Cubiella J, Salas D, Lanas A, Carballo F, Morillas JD, Hernández C, Jover R, Hijona E, Portillo I, Enríquez-Navascués JM, Hernández V, Martínez-Turnes A, Menéndez-Villalva C, González-Mao C, Sala T, Ponce M, Andrés M, Teruel G, Peris A, Sopeña F, González-Rubio F, Seoane-Urgorri A, Grau J, Serradesanferm A, Pozo À, Pellisé M, Balaguer F, Ono A, Cruzado J, Pérez-Riquelme F, Alonso-Abreu I, Carrillo-Palau M, de la Vega-Prieto M, Iglesias R, Amador J, Blanco JM, Sastre R, Ferrándiz J, González-Hernández MJ, Andreu M, Bessa X, COLONPREV Study Investigators.

2014-03-2712 citations

10.1016/j.cgh.2014.03.022

Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening.

Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas Á, Andreu M, Carballo F, Morillas JD, Hernández C, Jover R, Montalvo I, Arenas J, Laredo E, Hernández V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andrés M, Teruel G, Peris A, Roncales MP, Polo-Tomás M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Pérez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Díaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, González-Navarro A, COLONPREV Study Investigators.

2012-02-01639 citations

10.1056/nejmoa1108895

Interventions

PROCEDUREColonoscopy

Every 10 years, with sedation.

PROCEDUREImmunochemical fecal occult blood test

Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 69 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Colorectal cancer-related mortality	10 years

Secondary

Measure	Time frame
Colorectal cancer incidence	15 years
Adherence rate	10 years
Advanced colorectal neoplasm detection rate	2 years
Compliance rate	2 years
Complication rate	10 years

Countries

Spain

Outcome results

None listed