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Colorectal Cancer ScreeningPhase 3SUIVICOLONCT07520578

EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENING TEST. (SUIVICOLO)

A Phase 3 study testing Information leaflet about colonoscopy follow-up and Endorsement of CRCDC letters from the GP in people with Colorectal Cancer Screening, run by University Hospital, Caen at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To be effective, organized colorectal cancer screening requires good adherence to diagnostic colonoscopy in the event of a positive test. In France, the rate of diagnostic colonoscopy following a positive colorectal cancer screening test is less than 85%, and the median delay is close to 90 days. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Colorectal Cancer Screening
What is being tested?
Information leaflet about colonoscopy follow-up and Endorsement of CRCDC letters from the GP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
1 siteFrance
Study dates
24 Mar 2026to 24 Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 50 and 75 at the time of the positive colorectal cancer screening test
  • Residing in one of the departments of the Centre Val de Loire region
  • Date on which the positive CRC screening test result was sent to the beneficiary recorded
  • Colorectal cancer screening test results sent to the beneficiary within 30 days of the test being read
  • Affiliated with a health insurance fund

Who cannot join

  • Subjects who have notified their refusal to allow their data to be used for research purposes will be excluded from the analyses.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lydia GUITTET, MD,PhD contact

231065781 ext. +33

lydia.guittet@unicaen.fr

Arnaud ALVES, MD,PhD contact

231065781 ext. +33

alves-a@chu-caen.fr

France1 site, 1 recruiting

  • Crcdc-Cvl

    Tours, France, 37000

    Julie BOYARD, ScD, 749702336 ext. +33, j.boyard@crcdc-cvl.fr

    Somany VIDAL-SENGCHANH-VIDAL, s.sengchanh@depistage-cancer.fr

    Recruiting

Other trials in France

About this study

Official title: EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENING TEST, A RANDOMISED CONTROLLED TRIAL. (SUIVICOLO)

To be effective, organized colorectal cancer screening requires good adherence to diagnostic colonoscopy in the event of a positive test. In France, the rate of diagnostic colonoscopy following a positive colorectal cancer screening test is less than 85%, and the median delay is close to 90 days. After receiving their positive result from the laboratory, individuals with no known follow-up are contacted only six months later by the Regional Cancer Screening Coordination Centers (CRCDC) responsible for following up with individuals who have tested positive. To optimize follow-up with colonoscopy, earlier contact and information about colonoscopy appear to be necessary. The contribution of the general practitioner identified on the test could be an additional lever.

The SUIVICOLO study aims to evaluate the effectiveness on the rate of colonoscopies performed at 6 months of two strategies for optimizing the follow-up of positive results in comparison with control group C (current procedures of the CRCDC Centre Val de Loire without early letter).

Read more

The two strategies evaluated will be:

  • Group B1: Sending an early letter signed by the CRCDC accompanied by information leaflet about colonoscopy
  • Group B2: Sending an early letter co-signed by the CRCDC and the general practitioner (identified or provided by the patient on the test identification form) accompanied by information leaflet about colonoscopy.

These strategies will be compared to the current follow-up strategy in a three arm randomized controlled arm.

Being tested
Usual care follow-up by CRCDC, Information leaflet about colonoscopy follow-up, Endorsement of CRCDC letters from the GP
Keywords
Colonoscopy, Fecal immunochemical test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual care follow-up by CRCDCOther

    1. 6 months after positive test result: 1st reminder letter from the CRCDC if it has no information about a colonoscopy being performed
    2. 12 months after positive test result: 2nd reminder letter from the CRCDC if it has no information about a colonoscopy being performed
    3. 18 months after positive test result: 3rd reminder letter from the CRCDC if it has no information about a colonoscopy being performed

  • Information leaflet about colonoscopy follow-upOther

    An information leaflet about colonoscopy follow-up will be sent in an early letter 7 days after positive test result, and though QR-codes in subsequent reminders.

  • Endorsement of CRCDC letters from the GPOther

    Explicit mention of their general practitioner in letters and reminders sent by the CRCDC to individuals who have tested positive for colorectal cancer, including the information leaflet about colonoscopy or a link to this document (QR code).

Study groups in NCT07520578
Study groupRoleWhat they receive
Control group (usual care)Active comparatorNot described
Receives: Other: Usual care follow-up by CRCDC
Early letter with information leaflet about colonoscopyExperimentalB1
Receives: Other: Usual care follow-up by CRCDC; Other: Information leaflet about colonoscopy follow-up
Early letter endorsed by the GP with information leaflet about colonoscopyExperimentalB2
Receives: Other: Usual care follow-up by CRCDC; Other: Information leaflet about colonoscopy follow-up; Other: Endorsement of CRCDC letters from the GP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Colonoscopy rate at 6 months after a positive test

    Measured: 6 months

Secondary outcomes (12)

  1. Percentage of general practitioners who agreed to participate in the project

    Measured: At baseline

  2. Colonoscopy rates at 12 months after a positive test

    Measured: 12 months

  3. Colonoscopy rates at 18 months after a positive test

    Measured: 18 months

  4. Colonoscopy rates at 24 months after a positive test

    Measured: 24 months

  5. Number of reminders in each group by type of reminder

    Measured: 24 months

  6. Number of people with contraindications to colonoscopy

    Measured: 24 months

  7. Number of people with a CT colonography

    Measured: 24 months

  8. Time to perform colonoscopy

    Measured: 24 months

  9. Colorectal cancer at colonoscopy

    Measured: 24 months

  10. Advanced neoplasia at colonoscopy

    Measured: 24 months

  11. Number of people who refused colonoscopy

    Measured: 24 months

  12. Number of lost to follow-up

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start24 Mar 2026
  3. Primary completion24 Mar 2027 (estimated)
  4. Study completion24 Oct 2028 (estimated)

Resources

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 3
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a regional study controlled randomised into 3 parallel groups, comparing 2 interventions 'B1' and "B2" versus a control 'C' (Figure 2), stratified according to whether or not a general practitioner accepted to be associated to letters. Randomisation will be stratified according to whether the beneficiary indicated the name of a general practitioner on the document accompanying their screening test and, where applicable, whether the general practitioner agreed to be associated to the letter provided for in the study. Allocation would be 1:2:2 for control, intervention B1 and intervention B2 groups in case an agreeing GP is identified for the subject, and 1:1 for control and intervention B1 in the other case.
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07520578
Sponsor's protocol ID
2025-A01519-40
Acronym
SUIVICOLO
Status last verified
Feb 2026
First submitted
20 Mar 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Information leaflet about colonoscopy follow-up and Endorsement of CRCDC letters from the GP in people with Colorectal Cancer Screening, run by University Hospital, Caen at 1 site 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lydia GUITTET, MD,PhD (231065781 ext. +33, lydia.guittet@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Colonoscopy rate at 6 months after a positive test (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07520578.

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 18 Sep 2026.

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