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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Digital Training Program (Colo-ID)
  Structured educational program for endoscopists focused on optical polyp characterization. No direct intervention on patients.

Первичные конечные точки

• Change in Optical Histology Prediction Accuracy After Use of the Colo-ID Training Program [Срок оценки: Pre-training period and post-training period between February 2026 and June 2026.]

Вторичные конечные точки (6)

• Proportion of Polyps Eligible for Resect-and-Discard and Diagnose-and-Leave Strategies [Срок оценки: From February 2026 to June 2026.]
• Proportion of Advanced Lesions Among Polyps Considered Eligible for Discard [Срок оценки: From February 2026 to June 2026.]
• Inter-Operator Variability in Optical Prediction Accuracy [Срок оценки: Pre- and post-training periods between February 2026 and June 2026.]
• Individual and Collective Performance Evolution After Training [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Pre-training and post-training (within February 2026 to June 2026).]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Clinique Paris-Bercy — Charenton-le-Pont

Публикации

• 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
• 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 A PMID 32572858
• 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: Eu PMID 34872120

Идентификаторы

NCT: NCT07424391 · COLO-PREDICT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗