NCT00812942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,889

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
Last Updated

December 22, 2008

Status Verified

December 1, 2008

Enrollment Period

2 years

First QC Date

December 18, 2008

Last Update Submit

December 19, 2008

Conditions

Colorectal Cancer

Keywords

average-risk subjects for

Outcome Measures

Primary Outcomes (1)

  • Participation to colorectal cancer screening

Study Arms (2)

fobt

ACTIVE COMPARATOR

faecal occult blood test

Procedure: faecal test

colonoscopy

ACTIVE COMPARATOR

colonoscopy screening

Procedure: colonoscopy

Interventions

colonoscopyPROCEDURE

colonoscopy screening

colonoscopy
faecal testPROCEDURE

faecal occult blood test for screening

fobt

Eligibility Criteria

Age55 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • asymptomatic 55-64 years subjects

You may not qualify if:

  • already studied for colorectal cancer, severe comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IIstituto Nazionale Tumori Regina Elena

Rome, 00100, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 22, 2008

Study Start

November 1, 2003

Primary Completion

November 1, 2005

Study Completion

November 1, 2008

Last Updated

December 22, 2008

Record last verified: 2008-12

Locations

IT(1)