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

This study is ongoing, but not recruiting participants.

First Received on May 19, 2009. Last Updated on June 21, 2011 History of Changes

Sponsor:	Hospital Clinic of Barcelona
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

Purpose

Aims:

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.
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 III

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:

MedlinePlus related topics: Bowel Movement Cancer Colonoscopy Colorectal Cancer

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

No publications provided

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 February 09, 2012