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OpenTrials
Completed

NCT Number: NCT00906997

Colorectal Cancer Screening in Average-risk Population: 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).

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasm Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunochemical fecal occult blood test

Procedure

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

colonoscopy

Procedure

Every 10 years, with sedation.

Primary outcomes

  1. Colorectal cancer-related mortality

    Time frame: 10 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Fundacion Cientifica de la Asociacion Española contra el Cancer
  • Instituto de Salud Carlos III

Registry information

Official study title

Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.

Important dates

Study start
2008
Primary completion
2021
Study completion
2021
First posted
May 21, 2009
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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