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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812942
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: December 18, 2008
• Last updated: December 19, 2008
• Start date: November 2003
• Est. completion date: November 2008

Study information

• Verified date: December 2008
• Source: Istituto Superiore di Sanità
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9889
• Est. completion date: November 2008
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 64 Years

Eligibility

Inclusion Criteria:

• asymptomatic 55-64 years subjects

Exclusion Criteria:

• already studied for colorectal cancer, severe comorbidities

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• colonoscopy
colonoscopy screening
• faecal test
faecal occult blood test for screening

Locations

Country	Name	City	State
Italy	IIstituto Nazionale Tumori Regina Elena	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Superiore di Sanità

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation to colorectal cancer screening			No