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NCT Number: NCT05589675

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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. 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

Sponsors and collaborators

Lead sponsor

International Agency for Research on Cancer

Other

Registry information

Official study 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)

Acronym: KITCOLO22

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 21, 2022
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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