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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer Colorectal
• Intervention / Treatment: Behavioral: Reminder letter

• Study Type: Interventional
• Enrollment (Actual): 7101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Indre-et-Loire
    • Tours, Indre-et-Loire, France, 37000
      • UH Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reminder letter; A letter is sent for remind the importance of compliance with colonoscopy AND to encourage people to to consult their general practitioner or gastroenterologist (if they haven't done their follow-up in time).	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
No Intervention: Control; No intervention (what is done currently)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms	12 months after sending the letter (/randomization)

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Somany SENGCHANH, Dr, Centre de Coordination des Dépistages des Cancers CHRU de Tours; Principal Investigator: Ken HAGUENOER, Dr, Centre de Coordination des Dépistages des Cancers; Principal Investigator: Julie Boyard, Centre de Coordination des Dépistages des Cancers; Study Chair: Thierry Lecomte, Pr, CHRU de Tours, Service Hépato- gastroentérologie

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): May 23, 2018
• Study Completion (Actual): May 23, 2019

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: colonoscopy; screening; high risk; surveillance
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: INCa15-SS/ISIRECC; 2015-A01607-42 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No