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NCT07721987

Development and External Validation of a Machine Learning Model for Pre-Endoscopic Prediction of Montreal Disease Extent (E1/E2/E3) in Ulcerative Colitis Using Symptoms, Signs, and Laboratory Tests: A Multicenter Retrospective Observational Study

Sponsor: Beijing University of Chinese Medicine

View on ClinicalTrials.gov

Summary

This multicenter retrospective observational study aims to develop and externally validate a machine learning model that predicts Montreal ulcerative colitis (UC) disease extent (E1: limited/proctitis; E2: left-sided; E3: extensive) using pre-endoscopic clinical information, including symptoms, signs, and laboratory tests. The model is intended to assist clinical assessment before endoscopic confirmation and is not designed to replace colonoscopy or histopathology. Data from development centers (Centers A and B) will be used for model development with nested cross-validation; data from independent external centers (Centers C and D) will be used for external validation only.

Official title: Development and External Validation of a Machine Learning Model for Pre-Endoscopic Prediction of Montreal Disease Extent (E1/E2/E3) in Ulcerative Colitis

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2015-11-20

Completion Date

2026-09-01

Last Updated

2026-08-18

Healthy Volunteers

No