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Not yet recruiting 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)

Phase III Interventional Colorectal Cancer Screening

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Usual care follow-up by CRCDC, Information leaflet about colonoscopy follow-up, Endorsement of CRCDC letters from the GP.
Who it may be relevant to
Registry conditions: Colorectal Cancer Screening. Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)

Overview

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.

Interventions

  • Other Usual care follow-up by CRCDC
    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
  • 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).

Primary outcome measures

  • Colonoscopy rate at 6 months after a positive test [Time frame: 6 months]
Secondary outcome measures (12)
  • Percentage of general practitioners who agreed to participate in the project [Time frame: At baseline]
  • Colonoscopy rates at 12 months after a positive test [Time frame: 12 months]
  • Colonoscopy rates at 18 months after a positive test [Time frame: 18 months]
  • Colonoscopy rates at 24 months after a positive test [Time frame: 24 months]
  • Number of reminders in each group by type of reminder [Time frame: 24 months]
  • Number of people with contraindications to colonoscopy [Time frame: 24 months]
  • Number of people with a CT colonography [Time frame: 24 months]
  • Time to perform colonoscopy [Time frame: 24 months]
  • Colorectal cancer at colonoscopy [Time frame: 24 months]
  • Advanced neoplasia at colonoscopy [Time frame: 24 months]
  • Number of people who refused colonoscopy [Time frame: 24 months]
  • Number of lost to follow-up [Time frame: 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

France · 1 center
  • Crcdc-Cvl — Tours

Identifiers

NCT: NCT07520578 · 2025-A01519-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗