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NCT Number: NCT07520578

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)

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).

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Usual care follow-up by CRCDC

Other
  • 6 months after positive test result: 1st reminder letter from the CRCDC if it has no information about a colonoscopy being performed
  • 12 months after positive test result: 2nd reminder letter from the CRCDC if it has no information about a colonoscopy being performed
  • 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-up

Other

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 GP

Other

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).

Primary outcomes

  1. Colonoscopy rate at 6 months after a positive test

    Time frame: 6 months

Secondary outcomes

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

    Time frame: At baseline

  2. Colonoscopy rates at 12 months after a positive test

    Time frame: 12 months

  3. Colonoscopy rates at 18 months after a positive test

    Time frame: 18 months

  4. Colonoscopy rates at 24 months after a positive test

    Time frame: 24 months

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

    Time frame: 24 months

  6. Number of people with contraindications to colonoscopy

    Time frame: 24 months

  7. Number of people with a CT colonography

    Time frame: 24 months

  8. Time to perform colonoscopy

    Time frame: 24 months

  9. Colorectal cancer at colonoscopy

    Time frame: 24 months

  10. Advanced neoplasia at colonoscopy

    Time frame: 24 months

  11. Number of people who refused colonoscopy

    Time frame: 24 months

  12. Number of lost to follow-up

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Arnaud ALVES, MD,PhD

CONTACT

[email protected]

231065781 ext. +33

Lydia GUITTET, MD,PhD

CONTACT

[email protected]

231065781 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire
  • INSERM U1086 ANTICIPE - Université Caen Normandie
  • URPS Centre Val de Loire

Registry information

Official study 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)

Acronym: SUIVICOLO

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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