Clinical trial NCT02931825: Identification of High Risk People for Colorectal Cancer and Evaluation of a Specific Surveillance System
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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Colorectal
Keywords: high risk
surveillance
screening
colonoscopy
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 7101
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: 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)
timeFrame: one year
measure: Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms
timeFrame: 12 months after sending the letter (/randomization)
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: UH Tours
state: Indre-et-Loire
Study officials:
affiliation: Centre de Coordination des Dépistages des Cancers CHRU de Tours
name: Somany SENGCHANH, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de Coordination des Dépistages des Cancers
name: Ken HAGUENOER, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de Coordination des Dépistages des Cancers
name: Julie Boyard
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU de Tours, Service Hépato- gastroentérologie
name: Thierry Lecomte, Pr
role: STUDY_CHAIR
References: