Colorectal CancerKITCOLO22NCT05589675
Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program
A study testing Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program and Sending of a prior notification to the new entrants of the national program in people with Colorectal Cancer, run by International Agency for Research on Cancer at 3 sites in France.
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… Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program and Sending of a prior notification to the new entrants of the national program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71,117 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Apr 2023to 27 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Regional Cancer Screening Coordinating Centre, Ardennes site
Charleville-Mézières, Ardennes, 08000
Regional Cancer Screening Coordinating Centre, Moselle Site
Metz, Moselle, 57000
Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle Site
Nancy, Meurthe-et-Moselle, 54500
About this study
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)
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).
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program, Sending of a prior notification to the new entrants of the national program
- Keywords
- colorectal cancer, screening program, pilot project, randomised control trial, France
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dispatch of the screening test along the invitation letter to the national colorectal cancer screening programOther
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 programOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Invitation letter to the screening program with the FIT test Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rates to the screening program
Comparison of the participation rate to the screening program between the intervention and the control arms
Measured: 2 years
Secondary outcomes (2)
Referral rates to coloscopy among those FIT positive
Comparison of the referral rates to coloscopy between the intervention and the control arms
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Apr 2023
- Primary completion17 Jul 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a three-arm study with a parallel study design
- Masking
- None (open label)
- Enrolment
- 71,117 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Sauvaget, International Agency for Research on Cancer
- Investigators
- Maurice TANGUY, MD, Principal investigator, Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle site, Nancy, FranceMyriam GUERBAZ SOMMI, MD, Principal investigator, Regional Cancer Screening Coordinating Centre, Moselle site, Metz, FranceJean BOTO KEKY, MD, Principal investigator, Regional Cancer Screening Coordinating Centre, Ardennes site, Charleville-Mézières, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589675
- Sponsor's protocol ID
- IEC/22-29
- Acronym
- KITCOLO22
- Status last verified
- Aug 2026
- First submitted
- 18 Oct 2022
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05589675
- Acronym / sponsor ID
- KITCOLO22 / IEC/22-29
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, screening program, pilot project, randomised control trial, France
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71,117 participants (actual)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a three-arm study with a parallel study design
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Dispatch of the screening test along the invitation letter to the national colorectal cancer screening programInvitation letter to the screening program with the FIT test |
| Intervention arm - sub study | Experimental | 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 programPrior notification to the new entrants, followed by an invitation letter to the screening program with the FIT test |
| Control arm | No intervention | –Invitation letter to visit its own GP who will deliver the FIT test |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dispatch of the screening test along the invitation letter to the national colorectal cancer screening programThe 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 | Intervention arm, Intervention arm - sub study |
| Sending of a prior notification to the new entrants of the national programDispatch 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 | Other | Intervention arm - sub study |
Primary outcome
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 secondary outcomes
Referral rates to coloscopy among those FIT positive
Time frame: 2 years
Participation rates to the screening program
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice TANGUY, MD principal investigator
Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle site, Nancy, France
Myriam GUERBAZ SOMMI, MD principal investigator
Regional Cancer Screening Coordinating Centre, Moselle site, Metz, France
Jean BOTO KEKY, MD principal investigator
Regional Cancer Screening Coordinating Centre, Ardennes site, Charleville-Mézières, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program and Sending of a prior notification to the new entrants of the national program in people with Colorectal Cancer, run by International Agency for Research on Cancer at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rates to the screening program (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.