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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00812942
Enrollment
9889
Registered
2008-12-22
Start date
2003-11-30
Completion date
2008-11-30
Last updated
2008-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

average-risk subjects for

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.

Interventions

PROCEDUREcolonoscopy

colonoscopy screening

PROCEDUREfaecal test

faecal occult blood test for screening

Sponsors

Istituto Superiore di Sanità
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* asymptomatic 55-64 years subjects

Exclusion criteria

* already studied for colorectal cancer, severe comorbidities

Design outcomes

Primary

MeasureTime frame
Participation to colorectal cancer screening

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026