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

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Other: Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program; Other: Sending of a prior notification to the new entrants of the national program

• Registration Number: NCT05589675
• Lead Sponsor: International Agency for Research on Cancer

Brief Summary

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).

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 Timeline

• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Study Start: 2023-04-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29
• Primary Completion: 2025-12-17
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 64500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm - sub study	Sending of a prior notification to the new entrants of the national program	Prior notification to the new entrants, followed by an invitation letter to the screening program with the FIT test
Intervention arm - sub study	Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program	Prior notification to the new entrants, followed by an invitation letter to the screening program with the FIT test
Intervention arm	Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program	Invitation letter to the screening program with the FIT test

Primary Outcome Measures

Name	Time	Method
Participation rates to the screening program	2 years	Comparison of the participation rate to the screening program between the intervention and the control arms

Secondary Outcome Measures

Name	Time	Method
Referral rates to coloscopy among those FIT positive	2 years	Comparison of the referral rates to coloscopy between the intervention and the control arms
Participation rates to the screening program	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

Trial Locations

Locations (3)

Regional Cancer Screening Coordinating Centre, Ardennes site; 🇫🇷 Charleville-Mézières, Ardennes, France

Regional Cancer Screening Coordinating Centre, Moselle Site; 🇫🇷 Metz, Moselle, France

Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle Site; 🇫🇷 Nancy, Meurthe-et-Moselle, France