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

Not Applicable
Completed
Conditions
Colorectal Cancer
Interventions
Procedure: faecal test
Procedure: colonoscopy
Registration Number
NCT00812942
Lead Sponsor
Istituto Superiore di Sanità
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
9889
Inclusion Criteria
  • asymptomatic 55-64 years subjects
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Exclusion Criteria
  • already studied for colorectal cancer, severe comorbidities
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
fobtfaecal testfaecal occult blood test
colonoscopycolonoscopycolonoscopy screening
Primary Outcome Measures
NameTimeMethod
Participation to colorectal cancer screening
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

IIstituto Nazionale Tumori Regina Elena

🇮🇹

Rome, Italy

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