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

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.

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Key information

Conditions

Cancer Colorectal Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Tours

Tours, Indre-et-Loire, 37000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reminder Letter

Behavioral

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

Primary outcomes

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
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)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Acronym: ISIRECC

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Oct 13, 2016
Registry last updated: May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed