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NCT07721987Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 18 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1500 (estimated)
First submitted
19 Jul 2026
Start date
20 Nov 2015
Primary completion date
1 Aug 2026
Lead sponsor
Beijing University of Chinese Medicine
NCT number
NCT07721987

What you commit to

  • Study type: Observational
  • Planned participants: 1500
  • From 20 Nov 2015 to the primary completion date, 1 Aug 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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

Who the study is looking for

  • 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).

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.