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

NCT07721987 | Active Not Recruiting

• 1 other identifier: 2026BZYLL0603
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ulcerative Colitis (Disorder)

Outcome Measures

Primary Outcomes (1)

• Macro one-vs-rest area under the receiver operating characteristic curve (macro AUC-OVR) for three-class Montreal extent prediction (E1 vs E2 vs E3) in the external validation cohort (n=247).

  At index visit / endoscopic assessment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with UC from four hospitals in China (2020-2025). Development cohort: Centers A (Dongfang Hospital, BUCM) and B (Dongzhimen Hospital, BUCM). External validation cohort: Centers C (BUCM Third Affiliated Hospital) and D (Yantai Hospital of Traditional Chinese Medicine).

You may qualify if:

• Confirmed diagnosis of ulcerative colitis by endoscopy ± histopathology.
• Montreal disease extent classifiable as E1 (limited), E2 (intermediate/left-sided), or E3 (extensive) and mapped to study labels 1/2/3.
• Pre-endoscopic baseline data available: demographics, symptoms, signs, and laboratory tests used as model predictors.
• Predictors collected before or independent of endoscopic findings used for the outcome label (endoscopic extent not used as input).
• One index visit per patient (duplicate/non-index visits excluded).

You may not qualify if:

• Non-UC diagnosis or Montreal extent not assignable.
• Missing patient identifier/linkage or unlabelable outcome.
• Incomplete endoscopic gold standard for Montreal extent classification.
• Duplicate or non-index visits.
• Critical predictor data unavailable and not handled by the prespecified modeling pipeline

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead
• Yantai Penglai Traditional Chinese Medicine Hospital: collaborator
• Beijing University of Chinese Medicine Third Affiliated Hospital: collaborator
• Dongzhimen Hospital, Beijing: collaborator
• Dongfang Hospital Beijing University of Chinese Medicine: collaborator

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start: November 20, 2015
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share