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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00906997
Recruitment Status : Active, not recruiting
First Posted : May 21, 2009
Last Update Posted : April 1, 2015
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 (Responsible Party):
Antoni Castells, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE May 19, 2009
First Posted Date  ICMJE May 21, 2009
Last Update Posted Date April 1, 2015
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
Colorectal cancer-related mortality [ Time Frame: 10 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
  • Compliance rate [ Time Frame: 2 years ]
  • Complication rate [ Time Frame: 10 years ]
  • Colorectal cancer incidence [ Time Frame: 15 years ]
  • Adherence rate [ Time Frame: 10 years ]
  • Advanced colorectal neoplasm detection rate [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
Official Title  ICMJE Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.
Brief Summary

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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Colorectal Cancer
  • Colorectal Neoplasm
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Fecal occult blood testing
    Intervention: Procedure: Immunochemical fecal occult blood test
  • Active Comparator: Colonoscopy
    Intervention: Procedure: Colonoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2009)
55498
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00906997
Other Study ID Numbers  ICMJE COLONPREV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antoni Castells, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Antoni Castells, MD Hospital Clínic, Barcelona, Spain
Principal Investigator: Enrique Quintero, MD Hospital Universitario de Canarias, Tenerife, Spain
PRS Account Hospital Clinic of Barcelona
Verification Date March 2015

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