Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program (KITCOLO22)

August 24, 2026 updated by: Catherine Sauvaget, International Agency for Research on Cancer

Evaluation of the Home Delivery of the Screening Kit, and Impact of a Prior Notification Among New Participants to the National Organized Colorectal Cancer Screening Program (Among New Participants Only)

This is a randomized controlled trial comparing the effect on participation rates to colorectal cancer screening between an intervention arm (invitation letter to the screening program including a FIT test with or without prior notification) and a control arm with the standard of care (invitation letter to visit the GP who will deliver the FIT test).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The participation to the national screening program for colorectal cancer in France is low. In order to improve the performances of its organized program, the National Cancer Institute is planning to modify the invitation procedure. This is a pilot project and if an improvement in the program performances is reported, the invitation procedure may be scaled up.

Eligible individuals for colorectal cancer screening will be identified by the Regional Cancer Screening Coordinating Centre and randomized into the intervention or control arms. They will be followed for FIT test submission to the central laboratory (participation to screening). Those who did not send their test will receive reminder letters. Those who had a positive FIT test will be followed up for coloscopy referral, and result of the coloscopy. Comparison of the participation rates to screening program and to coloscopy among those with a positive FIT test will be compared between the two study arms.

Study Type

Interventional

Enrollment (Actual)

71117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ardennes
      • Charleville-Mézières, Ardennes, France, 08000
        • Regional Cancer Screening Coordinating Centre, Ardennes site
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54500
        • Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle Site
    • Moselle
      • Metz, Moselle, France, 57000
        • Regional Cancer Screening Coordinating Centre, Moselle Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women and men aged 50 to 74 years old
  • Living in the study area (Departments of Ardennes, Meurthe-et-Moselle, and Moselle, France)
  • At moderate risk of colorectal cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)

Exclusion Criteria:

  • Outside the target age (less than 50 years old, or 75 years and more)
  • Receiving the reminder letter
  • At high or very high risk of colorectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Invitation letter to the screening program with the FIT test
Other: Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program
The individuals eligible for the colorectal cancer screening program will receive at home an invitation letter to participate to the program along with a FIT test. The follow-up will be similar to the standard of care, i.e. reminder letters at 5 and 10 months if there is no participation, and reminders if no coloscopy after a positive FIT test
Experimental: Intervention arm - sub study
Prior notification to the new entrants, followed by an invitation letter to the screening program with the FIT test
Other: Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program
The individuals eligible for the colorectal cancer screening program will receive at home an invitation letter to participate to the program along with a FIT test. The follow-up will be similar to the standard of care, i.e. reminder letters at 5 and 10 months if there is no participation, and reminders if no coloscopy after a positive FIT test
Other: Sending of a prior notification to the new entrants of the national program
Dispatch of a notification, one month prior the dispatch of the screening test along the invitation letter. This intervention is among the new entrants to the national program
No Intervention: Control arm
Invitation letter to visit its own GP who will deliver the FIT test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation rates to the screening program
Time Frame: 2 years
Comparison of the participation rate to the screening program between the intervention and the control arms
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Referral rates to coloscopy among those FIT positive
Time Frame: 2 years
Comparison of the referral rates to coloscopy between the intervention and the control arms
2 years
Participation rates to the screening program
Time Frame: 2 years
Comparison of the participation rates to the screening program between the individuals aged 50-52 of the Intervention1 and the Intervention sub-study arms
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Agency for Research on Cancer

Investigators

  • Principal Investigator: Maurice TANGUY, MD, Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle site, Nancy, France
  • Principal Investigator: Myriam GUERBAZ SOMMI, MD, Regional Cancer Screening Coordinating Centre, Moselle site, Metz, France
  • Principal Investigator: Jean BOTO KEKY, MD, Regional Cancer Screening Coordinating Centre, Ardennes site, Charleville-Mézières, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

July 17, 2025

Study Completion (Actual)

October 27, 2025

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC/22-29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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