NCT02931825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,101

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

May 23, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

October 11, 2016

Last Update Submit

May 28, 2019

Conditions

Cancer Colorectal

Keywords

high risksurveillancescreeningcolonoscopy

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (2)

Reminder letter

EXPERIMENTAL

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

Control

NO INTERVENTION

No intervention (what is done currently)

Interventions

Reminder letterBEHAVIORAL

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

Reminder letter

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • residing in Indre et Loire (France)
  • with increased risk for colorectal cancer
  • who did not perform a colonoscopy in the past 58 months

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Tours

Tours, Indre-et-Loire, 37000, France

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Thierry Lecomte, Pr

    CHRU de Tours, Service Hépato- gastroentérologie

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 13, 2016

Study Start

May 23, 2017

Primary Completion

May 23, 2018

Study Completion

May 23, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)