Clinique Paris-Bercy
Charenton-le-Pont, Val de Marne, 94220, France
Location status: Recruiting
Location contact
David Karsenti, MD
CONTACT
David Karsenti, MD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07424391
Colorectal cancer prevention relies on high-quality colonoscopy and accurate optical characterization of colorectal polyps. Optical diagnosis may allow optimization of management strategies such as resect-and-discard for diminutive polyps, potentially improving efficiency in routine practice.
COLO-PREDICT is a prospective, single-center, observational study designed to evaluate the impact of a structured digital training program (Colo-ID, a digital application for colonic polyp characterisation training) on the accuracy of optical histology prediction of colorectal polyps in real-life clinical practice.
All consecutive adult patients undergoing colonoscopy with at least one detected polyp will be included. Optical prediction of polyp histology will be recorded during the procedure. All polyps will be resected and sent for histopathological analysis according to standard practice. No modification of patient management will occur as part of the study.
The primary objective is to assess the concordance between optical prediction and histopathology before and after implementation of the digital training program. Secondary objectives include evaluation of prediction performance according to polyp characteristics and assessment of potential implications for clinical practice.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Charenton-le-Pont, Val de Marne, 94220, France
Location status: Recruiting
David Karsenti, MD
CONTACT
David Karsenti, MD
PRINCIPAL_INVESTIGATOR
CONTACT
Colorectal cancer (CRC) prevention depends on the detection and removal of precursor lesions during colonoscopy. Optical diagnosis of colorectal polyps using enhanced imaging technologies has been proposed to improve procedural efficiency and to potentially support management strategies such as resect-and-discard for diminutive lesions. However, variability in optical characterization accuracy remains a major limitation in routine practice.
COLO-PREDICT is a prospective, single-center, observational study conducted in real-life clinical practice. The study aims to evaluate the impact of a structured digital training program (Colo-ID, a digital application for colonic polyp characterisation training) on the accuracy of optical histologic prediction of colorectal polyps.
Adult patients undergoing colonoscopy with at least one detected polyp will be consecutively included. During each procedure, the endoscopist will record an optical prediction of polyp histology based on standard classification systems and routine imaging modalities. All polyps will be resected and submitted for histopathological examination in accordance with current standard of care. No modification of patient management, surveillance interval, or therapeutic strategy will be implemented as part of the study.
The digital training program consists of a structured educational intervention focused on optical characterization principles, image-based training, and performance assessment in a simulated environment. The study evaluates optical prediction performance before and after implementation of this training program in routine practice.
The primary endpoint is the rate of concordance between optical histologic prediction and final histopathology. Secondary endpoints include diagnostic performance parameters (sensitivity, specificity, positive predictive value, negative predictive value), performance according to polyp size and location, and assessment of potential implications for clinical practice efficiency.
Data will be collected prospectively and analyzed using appropriate statistical methods to compare performance before and after training. The study is conducted in accordance with ethical and regulatory requirements and does not introduce additional risk for patients, as all clinical decisions follow standard practice.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Structured educational program for endoscopists focused on optical polyp characterization. No direct intervention on patients.
Time frame: Pre-training period and post-training period between February 2026 and June 2026.
Difference in overall accuracy of optical histologic prediction of colorectal polyps (agreement with final histopathology) between the pre-training period and the post-training period following implementation of the Colo-ID training program in routine clinical practice.
Time frame: From February 2026 to June 2026.
Proportion of detected polyps meeting guideline-based criteria for implementation of resect-and-discard or diagnose-and-leave strategies.
Time frame: From February 2026 to June 2026.
Rate of advanced histologic features among polyps classified as eligible for resect-and-discard or diagnose-and-leave strategies based on optical prediction.
Time frame: Pre- and post-training periods between February 2026 and June 2026.
Comparison of optical prediction accuracy across participating endoscopists and assessment of potential reduction in variability after training.
Time frame: Pre- and post-training periods between February 2026 and June 2026.
Change in individual and group-level optical prediction accuracy associated with routine use of the Colo-ID training tool.
Time frame: End of study analysis (June 2026).
Estimated potential reduction in histopathology analyses and associated costs and carbon footprint, calculated by multiplying the number of polyps deemed eligible for discard/leave by average unit cost and average unit environmental impact per pathology analysis.
Time frame: Pre-training and post-training (within February 2026 to June 2026).
Change in pre- vs post-training questionnaire responses using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). The questionnaire includes identical items before and after training and covers: (1) diagnostic confidence, (2) perceived ability to identify polyps eligible for resect-and-discard and diagnose-and-leave, (3) knowledge/adhesion to European Society of Gastrointestinal Endoscopy (ESGE) recommendations, and (4) perceived usefulness of the training program. Analyses will include the key item assessing readiness to implement Resect-and-Discard and Diagnose-and-Leave strategies in routine practice.
Contact information is provided by the study sponsor or research team.
Coralie Declerck, Ms.
CONTACT
David Karsenti, MD
CONTACT
Clinique Paris-Bercy
Other
Impact of a Digital Training Program (Colo-ID) on Optical Histologic Prediction and Management of Colorectal Polyps: A Prospective Study
Acronym: COLO-PREDICT
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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