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

NCT05589675 | Active Not Recruiting

• 1 other identifier: IEC/22-29
• Study Type: interventional
• Target: 64,500
• Locations: 1 country
• Sites: 3

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).

Conditions

Colorectal Cancer

Keywords

colorectal cancer; screening program; pilot project; randomised control trial; France

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Referral rates to coloscopy among those FIT positive

  2 years

• Participation rates to the screening program

  2 years

Study Arms (3)

Intervention arm

EXPERIMENTAL

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

Intervention arm - sub study

EXPERIMENTAL

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; Other: Sending of a prior notification to the new entrants of the national program

Control arm

NO INTERVENTION

Invitation letter to visit its own GP who will deliver the FIT test

Interventions

Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program OTHER

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

Intervention arm; Intervention arm - sub study

Sending of a prior notification to the new entrants of the national program OTHER

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

Intervention arm - sub study

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• International Agency for Research on Cancer: lead

Study Sites (3)

Regional Cancer Screening Coordinating Centre, Ardennes site

Charleville-Mézières, Ardennes, 08000, France

Location

Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle Site

Nancy, Meurthe-et-Moselle, 54500, France

Location

Regional Cancer Screening Coordinating Centre, Moselle Site

Metz, Moselle, 57000, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: This is a three-arm study with a parallel study design

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: April 1, 2023
• Primary Completion: July 17, 2025
• Study Completion: February 27, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)