COLO-PREDICT: Digital Training and Optical Diagnosis of Colorectal Polyps (COLO-PREDICT)

Impact of a Digital Training Program (Colo-ID) on Optical Histologic Prediction and Management of Colorectal Polyps: A Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Polyps
• Intervention / Treatment: Other: Digital Training Program (Colo-ID)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: David Karsenti, MD; Phone Number: +33145486565; Email: karsenti.paris@gmail.com
• Study Contact Backup: Name: Coralie Declerck, Ms.; Email: c.declerck@clinique-bercy.fr

Study Locations

• France
  • Val de Marne
    • Charenton-le-Pont, Val de Marne, France, 94220
      • Recruiting
      • Clinique Paris-Bercy
      • Principal Investigator: David KARSENTI, MD
      • Contact: David Karsenti, MD; Phone Number: 0143967850; Email: karsenti.paris@gmail.com
      • Contact: Email: karsenti.paris@gmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing colonoscopy in routine clinical practice at Clinique Paris-Bercy, in whom at least one colorectal polyp is detected and optically characterized by participating endoscopists. The study evaluates optical histology prediction performance before and after implementation of the Colo-ID digital training program. Histopathological analysis of resected polyps serves as the reference standard when applicable.

Description

Inclusion Criteria:

• Adults aged ≥18 years
• Patients undergoing colonoscopy in routine clinical practice at the participating center
• At least one colorectal polyp detected during colonoscopy
• Optical histology prediction recorded during the procedure
• Histopathological analysis available for resected polyps (reference standard)

Exclusion Criteria:

• Patients aged <18 years
• Refusal/opposition to use of data (if applicable under local regulations)
• Missing key study data (e.g., no recorded optical prediction or no histopathology result)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective Colonoscopy Cohort; Adult patients undergoing colonoscopy with at least one detected colorectal polyp. Optical histology prediction is recorded during routine clinical practice. All polyps are resected and sent for histopathological analysis according to standard care. No modification of patient management is performed as part of the study.	Other: Digital Training Program (Colo-ID); Structured educational program for endoscopists focused on optical polyp characterization. No direct intervention on patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Optical Histology Prediction Accuracy After Use of the Colo-ID Training Program	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.	Pre-training period and post-training period between February 2026 and June 2026.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Polyps Eligible for Resect-and-Discard and Diagnose-and-Leave Strategies	Proportion of detected polyps meeting guideline-based criteria for implementation of resect-and-discard or diagnose-and-leave strategies.	From February 2026 to June 2026.
Proportion of Advanced Lesions Among Polyps Considered Eligible for Discard	Rate of advanced histologic features among polyps classified as eligible for resect-and-discard or diagnose-and-leave strategies based on optical prediction.	From February 2026 to June 2026.
Inter-Operator Variability in Optical Prediction Accuracy	Comparison of optical prediction accuracy across participating endoscopists and assessment of potential reduction in variability after training.	Pre- and post-training periods between February 2026 and June 2026.
Individual and Collective Performance Evolution After Training	Change in individual and group-level optical prediction accuracy associated with routine use of the Colo-ID training tool.	Pre- and post-training periods between February 2026 and June 2026.
Estimated Potential Cost and Environmental Savings Associated With Resect-and-Discard and Diagnose-and-Leave Strategies Eligibility	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.	End of study analysis (June 2026).
Change in Questionnaire Score Assessing Confidence, Knowledge, and Readiness to Implement Resect-and-Discard and Diagnose-and-Leave Strategies	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.	Pre-training and post-training (within February 2026 to June 2026).

Collaborators and Investigators

• Sponsor: Clinique Paris-Bercy
• Investigators: Principal Investigator: David D Karsenti, Centre d'Explorations Digestives

Publications and helpful links

General Publications

• Rex DK, Kahi C, O'Brien M, Levin TR, Pohl H, Rastogi A, Burgart L, Imperiale T, Ladabaum U, Cohen J, Lieberman DA. The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2011 Mar;73(3):419-22. doi: 10.1016/j.gie.2011.01.023.
• Hassan C, Antonelli G, Dumonceau JM, Regula J, Bretthauer M, Chaussade S, Dekker E, Ferlitsch M, Gimeno-Garcia A, Jover R, Kalager M, Pellise M, Pox C, Ricciardiello L, Rutter M, Helsingen LM, Bleijenberg A, Senore C, van Hooft JE, Dinis-Ribeiro M, Quintero E. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 Aug;52(8):687-700. doi: 10.1055/a-1185-3109. Epub 2020 Jun 22.
• Houwen BBSL, Hassan C, Coupe VMH, Greuter MJE, Hazewinkel Y, Vleugels JLA, Antonelli G, Bustamante-Balen M, Coron E, Cortas GA, Dinis-Ribeiro M, Dobru DE, East JE, Iacucci M, Jover R, Kuvaev R, Neumann H, Pellise M, Puig I, Rutter MD, Saunders B, Tate DJ, Mori Y, Longcroft-Wheaton G, Bisschops R, Dekker E. Definition of competence standards for optical diagnosis of diminutive colorectal polyps: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2022 Jan;54(1):88-99. doi: 10.1055/a-1689-5130. Epub 2021 Dec 6.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 14, 2026
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Colonoscopy; Real-world study; Optical diagnosis; Endoscopic imaging; Histologic prediction; Resect-and-discard strategy; Digital training; Polyp characterization
• Other Study ID Numbers: COLO-PREDICT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie the results reported in this study (after de-identification) will be made available upon reasonable request to the corresponding investigator, subject to institutional approval and data use agreement.
• IPD Sharing Time Frame: IPD will be available upon reasonable request after publication of the main results and for 5 years thereafter.

IPD Sharing Access Criteria

De-identified individual participant data underlying the results reported in the publication (including polyp-level and operator-level data) will be available to researchers who provide a methodologically sound proposal.

Proposals should be directed to the principal investigator. Data will be shared after approval of a research proposal and signing of a data access agreement, in compliance with GDPR and applicable French regulations.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

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