Back to resultsParticipation to Colorectal Cancer Screening With Fecal Occult Blood Test and Colonoscopy
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
colonoscopy
faecal test
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring average-risk subjects for
Eligibility Criteria
Inclusion Criteria:
- asymptomatic 55-64 years subjects
Exclusion Criteria:
- already studied for colorectal cancer, severe comorbidities
Sites / Locations
- IIstituto Nazionale Tumori Regina Elena
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
fobt
colonoscopy
Arm Description
faecal occult blood test
colonoscopy screening
Outcomes
Primary Outcome Measures
Participation to colorectal cancer screening
Secondary Outcome Measures
Full Information
NCT ID
NCT00812942
First Posted
December 18, 2008
Last Updated
December 19, 2008
Sponsor
Istituto Superiore di Sanità
1. Study Identification
Unique Protocol Identification Number
NCT00812942
Brief Title
Participation to Colorectal Cancer Screening With Fecal Occult Blood Test and Colonoscopy
Official Title
Participation to Colorectal Cancer Screening With Faecal Occult Blood Test and Colonoscopy: an Italian, Multicenter, Randomized Population Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Istituto Superiore di Sanità
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
average-risk subjects for
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9889 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fobt
Arm Type
Active Comparator
Arm Description
faecal occult blood test
Arm Title
colonoscopy
Arm Type
Active Comparator
Arm Description
colonoscopy screening
Intervention Type
Procedure
Intervention Name(s)
colonoscopy
Intervention Description
colonoscopy screening
Intervention Type
Procedure
Intervention Name(s)
faecal test
Intervention Description
faecal occult blood test for screening
Primary Outcome Measure Information:
Title
Participation to colorectal cancer screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
asymptomatic 55-64 years subjects
Exclusion Criteria:
already studied for colorectal cancer, severe comorbidities
Facility Information:
Facility Name
IIstituto Nazionale Tumori Regina Elena
City
Rome
ZIP/Postal Code
00100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Participation to Colorectal Cancer Screening With Fecal Occult Blood Test and Colonoscopy
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