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

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: Colorectal Cancer
• Intervention / Treatment: Procedure: faecal test; Procedure: colonoscopy

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

• Sponsor: Istituto Superiore di Sanità

Study record dates

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: average-risk subjects for
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)