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Completed

NCT Number: NCT00812942

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

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.

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Key information

Age range

55 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IIstituto Nazionale Tumori Regina Elena

Rome, 00100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • asymptomatic 55-64 years subjects

Exclusion criteria

  • already studied for colorectal cancer, severe comorbidities

Treatment and study plan

colonoscopy

Procedure

colonoscopy screening

faecal test

Procedure

faecal occult blood test for screening

Primary outcomes

  1. Participation to colorectal cancer screening

Sponsors and collaborators

Lead sponsor

Istituto Superiore di Sanità

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2008
First posted
Dec 22, 2008
Registry last updated
Dec 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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