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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
History of Changes
  Purpose

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).


Condition Intervention Phase
Colorectal Cancer
Colorectal Neoplasm
 Procedure: Immunochemical fecal occult blood test
Procedure: Colonoscopy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Colorectal cancer-related mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 55498
Study Start Date: November 2008
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906997

Locations
Spain
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
Investigators
Principal Investigator: Antoni Castells, MD Hospital Clínic, Barcelona, Spain
Principal Investigator: Enrique Quintero, MD Hospital Universitario de Canarias, Tenerife, Spain
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Hospital Clinic of Barcelona

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

Responsible Party: Antoni Castells, MD and Enrique Quintero, MD, Gastroenterology Department, Hospital Clínic, Barcelona
ClinicalTrials.gov Identifier: NCT00906997     History of Changes
Other Study ID Numbers: COLONPREV
Study First Received: May 19, 2009
Last Updated: June 21, 2011
Health Authority: Spain: Ethics Committee
Spain: Ministry of Health and Consumption

Keywords provided by Hospital Clinic of Barcelona:
Colorectal cancer
Screening
Prevention
Fecal occult blood test
 Colonoscopy
Colorectal neoplasm
Randomized clinical trial

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

ClinicalTrials.gov processed this record on May 16, 2013