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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 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2026-07-23

No results posted yet for this study

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)

Sponsors & Collaborators

  • Yantai Penglai Traditional Chinese Medicine Hospital

    collaborator OTHER

  • Beijing University of Chinese Medicine Third Affiliated Hospital

    collaborator UNKNOWN

  • Dongzhimen Hospital, Beijing

    collaborator OTHER

  • Dongfang Hospital Beijing University of Chinese Medicine

    collaborator OTHER

  • Beijing University of Chinese Medicine

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-20
Primary Completion
2026-08-01
Completion
2026-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07721987 on ClinicalTrials.gov