- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06664567
Impact of a Proactive Strategy of General Practitioners on CRC Screening (DECORE)
September 10, 2025 updated by: University Hospital, Bordeaux
Impact of a Proactive Strategy of General Practitioners on CRC Screening: a Registry-based Cluster-based Randomized Controlled Trial
In this registry-based cluster randomized controlled trial, we will assess the impact of a proactive strategy of general practitioners (GP) who will systematically provide screening kits of colorectal cancer (CRC) to all patients of even age (50, 52, 54...up to 74 years) versus usual practice where the eligible population receive an invitation letter to visit the general practitioner and receive the screening kit.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer is one of the leading causes of cancer and death in France in both men and women.
The generalized screening rate is about 30% in France, far from the expected 65%, despite the fact that screening is free and a letter of invitation is sent to the individual's home, and despite the financial incentives provided to the practitioner.
Different studies have looked for the causes of non-implementation by the individual: negligence, "dirty"; forgetfulness, and the practitioner: organizational problem, communication problem.
A few intervention studies have been carried out with little success: sending the invitation to the individual's home, sending a letter of reminder, sending a letter of general information on screening to the practitioner, sending the list of patients who have not taken the test to the practitioner allows for a few percent improvement in screening.
In this registry-based cluster randomized controlled trial, we will assess the impact of a proactive strategy of general practitioners who will systematically provide screening kits of colorectal cancer to all patients of even age (50, 52, 54 years...up to 74 years) versus usual practice where the eligible population receive an invitation letter to visit the general practitioner and receive the screening kit.
The screening rate will be calculated for each arm at the end of the 2-year study with data from the health insurance.
Study Type
Observational
Enrollment (Estimated)
26260
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christele BLANC-BISSON, Dr
- Phone Number: +33 05 56 65 55 00
- Email: christele.blanc-bisson@u-bordeaux.fr
Study Contact Backup
- Name: Pierre POULIZAC
- Phone Number: +33 05 57 82 08 49
- Email: pierre.poulizac@chu-bordeaux.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Patient between 50 and 74 years old
Description
inclusion criteria:
- medical practices in Aquitaine region and their visiting patients eligible for colorectal cancer screening individuals aged between 50 and 74 years at intermediate risk of colorectal cancer).
Exclusion criteria:
- medical practices with less than five individual eligible for colorectal cancer screening.
- visiting patients aged less than 50 years or more than 74 years or at high or very high risk of colorectal cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Systematic provision of screening tests by GPs
The general practitioner systematically delivers the screening kit with justification and modalities of realization at an even age between 50 and 74 years to the patient who comes to consult for whatever reason, who is at intermediate risk of colorectal cancer and who falls under the generalized screening.
The practitioner is helped in his approach by an initial training in the identification of the age, delivery of a poster, a study sheet, stickers and goodies, sending a quarterly letter on the progress of the study and contact with the coordination team.
|
delivery of colorectal cancer screening test by GP
|
|
Delivery of screening test according to GP's usual practice
the GP will issue the CRC screening kit in accordance with his/her usual practice.
|
delivery of colorectal cancer screening test by GP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation rate in CRC screening
Time Frame: 2 years after the start of protocol
|
The primary endpoint of this trial is the rate of participation rate in CRC screening in the eligible patient population grouped with or without intervention.
This criterion will be measured by retrospective analysis of retrospective analysis of National Health Data System data.
|
2 years after the start of protocol
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive test results
Time Frame: 2 years after the start of protocol
|
Rate of patients with positive test results
|
2 years after the start of protocol
|
|
Positive test at an early stage
Time Frame: 2 years after the start of protocol
|
rate of patients tested positive at an early stage
|
2 years after the start of protocol
|
|
Positive test at a last stage
Time Frame: 2 years after the start of protocol
|
rate of patients testing positive at a late stage
|
2 years after the start of protocol
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
October 28, 2024
First Submitted That Met QC Criteria
October 28, 2024
First Posted (Actual)
October 29, 2024
Study Record Updates
Last Update Posted (Estimated)
September 11, 2025
Last Update Submitted That Met QC Criteria
September 10, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2021/64
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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