Participation to Colorectal Cancer Screening With Fecal Occult Blood Test and 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. Identifier: NCT00812942
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : December 22, 2008
Information provided by:
Istituto Superiore di Sanità

Brief Summary:
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 or disease Intervention/treatment
Colorectal Cancer Procedure: colonoscopy Procedure: faecal test

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9889 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2003
Primary Completion Date : November 2005
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Participation to colorectal cancer screening

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • asymptomatic 55-64 years subjects

Exclusion Criteria:

  • already studied for colorectal cancer, severe comorbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00812942

IIstituto Nazionale Tumori Regina Elena
Rome, Italy, 00100
Sponsors and Collaborators
Istituto Superiore di Sanità Identifier: NCT00812942     History of Changes
Other Study ID Numbers: 1
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: December 22, 2008
Last Verified: December 2008

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

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