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

March 12, 2025 updated by: Antoni Castells, Hospital Clinic of Barcelona

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55498

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 10 years
10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLONPREV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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