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

Colorectal Cancer Clinical Trial

— KITCOLO22  

Official title:

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05589675
• Other study ID #: IEC/22-29
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: September 2023
• Source: International Agency for Research on Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 64500
• Est. completion date: June 30, 2026
• Est. primary completion date: December 17, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
International Agency for Research on Cancer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation rates to the screening program	Comparison of the participation rate to the screening program between the intervention and the control arms	2 years
Secondary	Referral rates to coloscopy among those FIT positive	Comparison of the referral rates to coloscopy between the intervention and the control arms	2 years
Secondary	Participation rates to the screening program	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