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

Istituto Superiore di Sanità

Status: Completed

Conditions: Colorectal Cancer

Treatments: Procedure: colonoscopy; Procedure: faecal test

Study type: Interventional

Funder types: Other

Identifiers

NCT00812942

1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,889 patients

Sex: All

Ages: 55 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• asymptomatic 55-64 years subjects

Exclusion criteria

• already studied for colorectal cancer, severe comorbidities

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9,889 participants in 2 patient groups

fobt

Active Comparator group

Description:

faecal occult blood test

Treatment:

Procedure: faecal test

colonoscopy

Active Comparator group

Description:

colonoscopy screening

Treatment:

Procedure: colonoscopy