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Participation to Colorectal Cancer Screening With Fecal Occult Blood Test and Colonoscopy

This study has been completed.
Sponsor:
Information provided by:
Istituto Superiore di Sanita
ClinicalTrials.gov Identifier:
NCT00812942
First received: December 18, 2008
Last updated: December 19, 2008
Last verified: December 2008
History of Changes
  Purpose

Adherence rate to screening colonoscopy (TC) in the average-risk general population is still unclear. Aim of this study was to compare the uptake of TC screening with that of fecal occult blood (FOBT) in the general population of different Italian areas.


Condition Intervention
Colorectal Cancer
 Procedure: colonoscopy
Procedure: faecal test

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Participation to Colorectal Cancer Screening With Faecal Occult Blood Test and Colonoscopy: an Italian, Multicenter, Randomized Population Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Istituto Superiore di Sanita:

Primary Outcome Measures:
  • Participation to colorectal cancer screening [ Designated as safety issue: No ]

Enrollment: 9889
Study Start Date: November 2003
Study Completion Date: November 2008
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fobt
faecal occult blood test
 Procedure: faecal test
faecal occult blood test for screening
Active Comparator: colonoscopy
colonoscopy screening
 Procedure: colonoscopy
colonoscopy screening

Detailed Description:

A nationwide, population-based, multicenter, randomized trial comparing attendance to TC with that to FOBT was performed. Sixty-four general practitioners (GPs), overall including in their lists 9,889 average-risk subjects aged 55-64 years, were randomized between TC and FOBT screening programs. Eligible subjects were mailed a personal invitation letter co-signed by their GP and the coordinator of the area-reference GI centre. Attendance rate and detection rate for advanced neoplasia (colorectal cancer, adenoma >10 mm or with villous histology or high-grade dysplasia) for each arm of the study were assessed.

  Eligibility

Ages Eligible for Study:   55 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • asymptomatic 55-64 years subjects

Exclusion Criteria:

  • already studied for colorectal cancer, severe comorbidities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812942

Locations
Italy
IIstituto Nazionale Tumori Regina Elena
Rome, Italy, 00100
Sponsors and Collaborators
Istituto Superiore di Sanita
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00812942     History of Changes
Other Study ID Numbers: 1
Study First Received: December 18, 2008
Last Updated: December 19, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by Istituto Superiore di Sanita:
average-risk subjects for

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

ClinicalTrials.gov processed this record on June 18, 2013