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

NCT ID: NCT02931825

Last Updated: 2019-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2019-05-23

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Colorectal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Reminder letter

Intervention Type 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

Control

No intervention (what is done currently)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Somany SENGCHANH, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre de Coordination des Dépistages des Cancers CHRU de Tours

Ken HAGUENOER, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre de Coordination des Dépistages des Cancers

Julie Boyard

Role: PRINCIPAL_INVESTIGATOR

Centre de Coordination des Dépistages des Cancers

Thierry Lecomte, Pr

Role: STUDY_CHAIR

CHRU de Tours, Service Hépato- gastroentérologie

Locations

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UH Tours

Tours, Indre-et-Loire, France

Site Status

Countries

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France

Other Identifiers

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2015-A01607-42

Identifier Type: OTHER

Identifier Source: secondary_id

INCa15-SS/ISIRECC

Identifier Type: -

Identifier Source: org_study_id

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