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Clinical Trials/NCT02931825
NCT02931825
Completed
Not Applicable

Identification of High Risk People for Colorectal Cancer in Indre-et-Loire (France) and Evaluation of a Specific Surveillance System : a Randomized Trial Assessing the Efficacy of a Letter Encouraging People to Perform Colonoscopy Screening

University Hospital, Tours1 site in 1 country7,101 target enrollmentMay 23, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer Colorectal
Sponsor
University Hospital, Tours
Enrollment
7101
Locations
1
Primary Endpoint
Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. But this compliance with colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve compliance.

The purpose of this project is to to offer and evaluate the feasibility and the effectiveness of a specific surveillance system for high risk people for colorectal cancer

The project will be divided into 2 phases:

Objectives of the first phase:

  • Identify high risk people for colorectal cancer in the department of Indre-et-Loire,
  • Fill in as completely as possible their colonoscopic history in the past 5 years,
  • Estimate the proportion of high risk people for colorectal cancer in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years).

Objective of the second phase:

Compare the performed colonoscopy rate of high risk people for colorectal cancer without notion of colonoscopy in the past 58 months following or not (control group) the sending of a letter reminding the importance of compliance with colonoscopy.

Registry
clinicaltrials.gov
Start Date
May 23, 2017
End Date
May 23, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • residing in Indre et Loire (France)
  • with increased risk for colorectal cancer
  • who did not perform a colonoscopy in the past 58 months

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms

Time Frame: 12 months after sending the letter (/randomization)

Calculate the rate of high risk people for colorectal cancer identified in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years)

Time Frame: one year

Study Sites (1)

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