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.

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).

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colorectal Neoplasm
• Intervention / Treatment: Procedure: Immunochemical fecal occult blood test; Procedure: Colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 55498
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital del Mar
  • Madrid, Spain
    • Hospital Clínico
  • Murcia, Spain
    • Hospital Universitario Virgen de la Arrixaca
  • Ourense, Spain
    • Hospital Meixoeiro
  • San Sebastián, Spain
    • Hospital de Donosti
  • Tenerife, Spain
    • Hospital Universitario de Canarias
  • Valencia, Spain
    • Comunidad Valencia
  • Zaragoza, Spain
    • Hospital Clinico Lozano Blesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fecal occult blood testing; Fecal immunochemical testing biennially	Procedure: Immunochemical fecal occult blood test; Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.
Active Comparator: Colonoscopy; Colonoscopy one time	Procedure: Colonoscopy; Every 10 years, with sedation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Colorectal cancer-related mortality	10 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Instituto de Salud Carlos III; Fundacion Cientifica de la Asociacion Española contra el Cancer
• Investigators: Principal Investigator: Antoni Castells, MD, Hospital Clinic, Barcelona, Spain; Principal Investigator: Enrique Quintero, MD, Hospital Universitario de Canarias, Tenerife, Spain

Publications and helpful links

General Publications

• Shaukat 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.
• Salas D, Vanaclocha M, Ibanez J, Molina-Barcelo A, Hernandez V, Cubiella J, Zubizarreta R, Andreu M, Hernandez C, Perez-Riquelme F, Cruzado J, Carballo F, Bujanda L, Sarasqueta C, Portillo I, de la Vega-Prieto M, Morillas JD, Valentin V, Lanas A, Quintero E, Castells A. Participation and detection rates by age and sex for colonoscopy versus fecal immunochemical testing in colorectal cancer screening. Cancer Causes Control. 2014 Aug;25(8):985-97. doi: 10.1007/s10552-014-0398-y. Epub 2014 May 24.
• Castells A, Quintero E, Alvarez C, Bujanda L, Cubiella J, Salas D, Lanas A, Carballo F, Morillas JD, Hernandez C, Jover R, Hijona E, Portillo I, Enriquez-Navascues JM, Hernandez V, Martinez-Turnes A, Menendez-Villalva C, Gonzalez-Mao C, Sala T, Ponce M, Andres M, Teruel G, Peris A, Sopena F, Gonzalez-Rubio F, Seoane-Urgorri A, Grau J, Serradesanferm A, Pozo A, Pellise M, Balaguer F, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, Carrillo-Palau M, de la Vega-Prieto M, Iglesias R, Amador J, Blanco JM, Sastre R, Ferrandiz J, Gonzalez-Hernandez MJ, Andreu M, Bessa X; COLONPREV Study Investigators. Rate of detection of advanced neoplasms in proximal colon by simulated sigmoidoscopy vs fecal immunochemical tests. Clin Gastroenterol Hepatol. 2014 Oct;12(10):1708-16.e4. doi: 10.1016/j.cgh.2014.03.022. Epub 2014 Mar 27.
• Hernandez V, Cubiella J, Gonzalez-Mao MC, Iglesias F, Rivera C, Iglesias MB, Cid L, Castro I, de Castro L, Vega P, Hermo JA, Macenlle R, Martinez-Turnes A, Martinez-Ares D, Estevez P, Cid E, Vidal MC, Lopez-Martinez A, Hijona E, Herreros-Villanueva M, Bujanda L, Rodriguez-Prada JI; COLONPREV Study Investigators. Fecal immunochemical test accuracy in average-risk colorectal cancer screening. World J Gastroenterol. 2014 Jan 28;20(4):1038-47. doi: 10.3748/wjg.v20.i4.1038.
• Bujanda L, Lanas A, Quintero E, Castells A, Sarasqueta C, Cubiella J, Hernandez V, Morillas JD, Perez-Fernandez T, Salas D, Andreu M, Carballo F, Bessa X, Cosme A, Jover R; COLONPREV Study Investigators. Effect of aspirin and antiplatelet drugs on the outcome of the fecal immunochemical test. Mayo Clin Proc. 2013 Jul;88(7):683-9. doi: 10.1016/j.mayocp.2013.04.016. Epub 2013 Jun 7.
• Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales MP, Polo-Tomas M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Diaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, Gonzalez-Navarro A; COLONPREV Study Investigators. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895. Erratum In: N Engl J Med. 2016 May 12;374(19):1898. doi: 10.1056/NEJMx150040.

Helpful Links

• Webpage of the Spanish Gastroenterological Association, which endorses COLONPREV trial

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2008
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 19, 2009
• First Submitted That Met QC Criteria: May 19, 2009
• First Posted (Estimated): May 21, 2009

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Colorectal cancer; Screening; Prevention; Colonoscopy; Colorectal neoplasm; Fecal occult blood test
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: COLONPREV