MedDataX Logo

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

NCT ID: NCT00812942

Last Updated: 2008-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9889 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

average-risk subjects for

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

fobt

faecal occult blood test

Group Type ACTIVE_COMPARATOR

faecal test

Intervention Type PROCEDURE

faecal occult blood test for screening

colonoscopy

colonoscopy screening

Group Type ACTIVE_COMPARATOR

colonoscopy

Intervention Type PROCEDURE

colonoscopy screening

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

colonoscopy

colonoscopy screening

Intervention Type PROCEDURE

faecal test

faecal occult blood test for screening

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* asymptomatic 55-64 years subjects

Exclusion Criteria

* already studied for colorectal cancer, severe comorbidities
Minimum Eligible Age

55 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Superiore di Sanità

OTHER

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IIstituto Nazionale Tumori Regina Elena

Rome, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1

Identifier Type: -

Identifier Source: org_study_id