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

Primary Purpose

Cancer Colorectal

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Reminder letter
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cancer Colorectal focused on measuring high risk, surveillance, screening, colonoscopy

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UH Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reminder letter

Control

Arm Description

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).

No intervention (what is done currently)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 11, 2016
Last Updated
May 28, 2019
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02931825
Brief Title
Identification of High Risk People for Colorectal Cancer and Evaluation of a Specific Surveillance System
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
May 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Colorectal
Keywords
high risk, surveillance, screening, colonoscopy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reminder letter
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention (what is done currently)
Intervention Type
Behavioral
Intervention Name(s)
Reminder letter
Intervention Description
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 Outcome Measure Information:
Title
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
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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: - none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Somany SENGCHANH, Dr
Organizational Affiliation
Centre de Coordination des Dépistages des Cancers CHRU de Tours
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ken HAGUENOER, Dr
Organizational Affiliation
Centre de Coordination des Dépistages des Cancers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie Boyard
Organizational Affiliation
Centre de Coordination des Dépistages des Cancers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thierry Lecomte, Pr
Organizational Affiliation
CHRU de Tours, Service Hépato- gastroentérologie
Official's Role
Study Chair
Facility Information:
Facility Name
UH Tours
City
Tours
State/Province
Indre-et-Loire
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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