Participation to Colorectal Cancer Screening With Fecal Occult Blood Test and Colonoscopy - Full Text View

Sponsored by:	Istituto Superiore di Sanita
Information provided by:	Istituto Superiore di Sanita
ClinicalTrials.gov Identifier:	NCT00812942

Purpose

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.

Condition	Intervention
Colorectal Cancer	Procedure: colonoscopy Procedure: faecal test

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Participation to Colorectal Cancer Screening With Faecal Occult Blood Test and Colonoscopy: an Italian, Multicenter, Randomized Population Study

Further study details as provided by Istituto Superiore di Sanita:

Primary Outcome Measures:

Participation to colorectal cancer screening [ Designated as safety issue: No ]

Enrollment:	9889
Study Start Date:	November 2003
Study Completion Date:	November 2008
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
fobt: Active Comparator faecal occult blood test	Procedure: faecal test faecal occult blood test for screening
colonoscopy: Active Comparator colonoscopy screening	Procedure: colonoscopy colonoscopy screening

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.

Eligibility

Ages Eligible for Study:	55 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

asymptomatic 55-64 years subjects

Exclusion Criteria:

already studied for colorectal cancer, severe comorbidities

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812942

Locations

Italy
IIstituto Nazionale Tumori Regina Elena
rome, Italy, 00100

Sponsors and Collaborators

Istituto Superiore di Sanita

More Information

Study ID Numbers:	1
Study First Received:	December 18, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812942
Health Authority:	Italy: Ethics Committee

Keywords provided by Istituto Superiore di Sanita:

average-risk subjects for

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009