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

NCT07424391 | Recruiting

• 1 other identifier: COLO-PREDICT
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Polyps

Keywords

Optical diagnosis; Colonoscopy; Histologic prediction; Resect-and-discard strategy; Digital training; Endoscopic imaging; Polyp characterization; Real-world study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of Polyps Eligible for Resect-and-Discard and Diagnose-and-Leave Strategies

  From February 2026 to June 2026.

• Proportion of Advanced Lesions Among Polyps Considered Eligible for Discard

  From February 2026 to June 2026.

• Inter-Operator Variability in Optical Prediction Accuracy

  Pre- and post-training periods between February 2026 and June 2026.

• Individual and Collective Performance Evolution After Training

  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

  End of study analysis (June 2026).

Study Arms (1)

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)

Interventions

Digital Training Program (Colo-ID) OTHER

Structured educational program for endoscopists focused on optical polyp characterization. No direct intervention on patients.

Prospective Colonoscopy Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinique Paris-Bercy: lead

Study Sites (1)

Clinique Paris-Bercy

Charenton-le-Pont, Val de Marne, 94220, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 21353837 BACKGROUND

• 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.

  PMID: 32572858 BACKGROUND

• 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.

  PMID: 34872120 BACKGROUND

Study Officials

• David D Karsenti

  Centre d'Explorations Digestives

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Karsenti, MD

CONTACT

+33145486565; karsenti.paris@gmail.com

Coralie Declerck, Ms.

CONTACT

c.declerck@clinique-bercy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD will be available upon reasonable request after publication of the main results and for 5 years thereafter.
• 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.

Locations

FR (1)