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

December 19, 2008 updated by: Istituto Superiore di Sanità

Participation to Colorectal Cancer Screening With Faecal Occult Blood Test and Colonoscopy: an Italian, Multicenter, Randomized Population Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

9889

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00100
        • IIstituto Nazionale Tumori Regina Elena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • asymptomatic 55-64 years subjects

Exclusion Criteria:

  • already studied for colorectal cancer, severe comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Participation to colorectal cancer screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Superiore di Sanità

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

December 22, 2008

Last Update Submitted That Met QC Criteria

December 19, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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