CClinicalTrials.gg
CompletedNCT02931825ISIRECCUpdated May 30, 2019

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

An interventional study of Reminder letter in Cancer Colorectal, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2019-05-30.

Sponsored by University Hospital, Tours · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
7,101
Allocation
Randomized
Ages
50 Years to 74 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer Colorectal

Keywords

  • high risk
  • surveillance
  • screening
  • colonoscopy
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 7,101 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • none
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7,101 participants (actual)

Study arms

  • Experimental
    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).

    Behavioral: Reminder letter

  • No intervention
    Control

    No intervention (what is done currently)

Interventions

  • BehavioralReminder 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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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)

07

Study locations

1 site
  • UH Tours
    Tours, Indre-et-Loire 37000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02931825
Lead sponsor
University Hospital, Tours
Responsible party
Sponsor
First posted
Oct 13, 2016
Start date
May 23, 2017
Primary completion
May 23, 2018
Completion
May 23, 2019
Last update
May 30, 2019

Study contacts

Somany SENGCHANH, Dr
principal investigator · Centre de Coordination des Dépistages des Cancers CHRU de Tours
Ken HAGUENOER, Dr
principal investigator · Centre de Coordination des Dépistages des Cancers
Julie Boyard
principal investigator · Centre de Coordination des Dépistages des Cancers
Thierry Lecomte, Pr
study chair · CHRU de Tours, Service Hépato- gastroentérologie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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