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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00906997
Recruitment Status : Active, not recruiting
First Posted : May 21, 2009
Last Update Posted : April 1, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:


  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).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Neoplasm Procedure: Immunochemical fecal occult blood test Procedure: Colonoscopy Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.
Study Start Date : November 2008
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Colorectal cancer-related mortality [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Compliance rate [ Time Frame: 2 years ]
  2. Complication rate [ Time Frame: 10 years ]
  3. Colorectal cancer incidence [ Time Frame: 15 years ]
  4. Adherence rate [ Time Frame: 10 years ]
  5. Advanced colorectal neoplasm detection rate [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906997

Hospital del Mar
Barcelona, Spain
Hospital Clínico
Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Meixoeiro
Ourense, Spain
Hospital de Donosti
San Sebastián, Spain
Hospital Universitario de Canarias
Tenerife, Spain
Comunidad Valencia
Valencia, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Spain
Sponsors and Collaborators
Hospital Clinic of Barcelona
Grupo Cooperativo para el Cribado del Cancer Colorrectal en España.
Gastrointestinal Oncology Group of the Spanish Gastroenterological Association
Fundacion Cientifica de la Asociacion Española contra el Cancer
Instituto de Salud Carlos III
Principal Investigator: Antoni Castells, MD Hospital Clínic, Barcelona, Spain
Principal Investigator: Enrique Quintero, MD Hospital Universitario de Canarias, Tenerife, Spain
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. 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.

Responsible Party: Antoni Castells, Co-principal investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00906997     History of Changes
Other Study ID Numbers: COLONPREV
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Antoni Castells, Hospital Clinic of Barcelona:
Colorectal cancer
Fecal occult blood test
Colorectal neoplasm
Randomized clinical trial

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases