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) (SUIVICOLO)

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).

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Other: Usual care follow-up by CRCDC; Other: Information leaflet about colonoscopy follow-up; Other: Endorsement of CRCDC letters from the GP

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lydia GUITTET, MD,PhD; Phone Number: +33 231065781; Email: lydia.guittet@unicaen.fr
• Study Contact Backup: Name: Arnaud ALVES, MD,PhD; Phone Number: +33 231065781; Email: alves-a@chu-caen.fr

Study Locations

• France
  • France
    • Tours, France, France, 37000
      • Crcdc-Cvl
      • Principal Investigator: Julie BOYARD, ScD
      • Contact: Julie BOYARD, ScD; Phone Number: +33 749702336; Email: j.boyard@crcdc-cvl.fr
      • Contact: Somany VIDAL-SENGCHANH-VIDAL; Email: s.sengchanh@depistage-cancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group (usual care)	Other: Usual care follow-up by CRCDC; 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
Experimental: Early letter with information leaflet about colonoscopy; B1	Other: Usual care follow-up by CRCDC; 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; Other: Information leaflet about colonoscopy follow-up; 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.
Experimental: Early letter endorsed by the GP with information leaflet about colonoscopy; B2	Other: Usual care follow-up by CRCDC; 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; Other: Information leaflet about colonoscopy follow-up; 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.; Other: Endorsement of CRCDC letters from the GP; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Colonoscopy rate at 6 months after a positive test	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of general practitioners who agreed to participate in the project	At baseline
Colonoscopy rates at 12 months after a positive test	12 months
Colonoscopy rates at 18 months after a positive test	18 months
Colonoscopy rates at 24 months after a positive test	24 months
Number of reminders in each group by type of reminder	24 months
Number of people with contraindications to colonoscopy	24 months
Number of people with a CT colonography	24 months
Time to perform colonoscopy	24 months
Colorectal cancer at colonoscopy	24 months
Advanced neoplasia at colonoscopy	24 months
Number of people who refused colonoscopy	24 months
Number of lost to follow-up	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Centre Régional de Coordination du Dépistage des Cancers - Centre Val de Loire; INSERM U1086 ANTICIPE - Université Caen Normandie; URPS Centre Val de Loire
• Investigators: Study Director: Lydia GUITTET, MD,PhD, Caen Normandy University - INSERM U1086 ANTICIPE - Caen University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 24, 2026
• Primary Completion (Estimated): March 24, 2027
• Study Completion (Estimated): October 24, 2028

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Colonoscopy; Fecal immunochemical test
• Other Study ID Numbers: 2025-A01519-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No