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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00906997
First received: May 19, 2009
Last updated: June 21, 2011
Last verified: June 2011

May 19, 2009
June 21, 2011
November 2008
November 2021   (final data collection date for primary outcome measure)
Colorectal cancer-related mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00906997 on ClinicalTrials.gov Archive Site
  • Compliance rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Complication rate [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Colorectal cancer incidence [ Time Frame: 15 years ] [ Designated as safety issue: No ]
  • Adherence rate [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Advanced colorectal neoplasm detection rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • Colorectal Cancer
  • Colorectal Neoplasm
  • Procedure: Immunochemical fecal occult blood test
    Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.
  • Procedure: Colonoscopy
    Every 10 years, with sedation.
  • Active Comparator: Fecal occult blood testing
    Intervention: Procedure: Immunochemical fecal occult blood test
  • Active Comparator: Colonoscopy
    Intervention: Procedure: Colonoscopy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
55498
November 2021
November 2021   (final data collection date for primary outcome measure)

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
Both
50 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00906997
COLONPREV
Yes
Antoni Castells, MD and Enrique Quintero, MD, Gastroenterology Department, Hospital Clínic, Barcelona
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
Hospital Clinic of Barcelona
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP