Identification of High Risk People for Colorectal Cancer and Evaluation of a Specific Surveillance System

Cancer Colorectal Clinical Trial

— ISIRECC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931825
• Other study ID #: INCa15-SS/ISIRECC
• Secondary ID: 2015-A01607-42
• Status: Completed
• Phase: N/A
• Start date: May 23, 2017
• Est. completion date: May 23, 2019

Study information

• Verified date: May 2019
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7101
• Est. completion date: May 23, 2019
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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:

• none

Related Conditions & MeSH terms

• Cancer Colorectal
• Colorectal Neoplasms

Intervention

Behavioral:
• Reminder letter
The letter will consist in several parts: Reminder of : -the need of individual follow-up for high risk people for colorectal cancer AND - the general recommendations (one colonoscopy every 5 years) Recommendation to consult their general practitioner or gastroenterologist if they haven't done their follow up Request information if they've done their follow-up or if we have incorrect information Indication that the letter is sent as part of a surveillance program specific for high risk people for colorectal Cancer

Locations

Country	Name	City	State
France	UH Tours	Tours	Indre-et-Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		one year
Primary	Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms		12 months after sending the letter (/randomization)