Cure8
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
ClinicalTrials.gov

Cure8 trial brief

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

1 min read

Why This Matters

A validated pre-endoscopic model could help estimate UC disease extent before colonoscopy, aiding clinical triage and planning without replacing endoscopy.

Who Should Pay Attention

Clinicians (gastroenterologists, IBD nurses), researchers in AI/IBD diagnostics, and adult patients interested in noninvasive disease assessment

Study Snapshot

Story typeClinical Reference
Evidence typeClinical trial
Enrollment1,500 participants
Study statusActive_not_recruiting
Source depthTrial registry record

What To Know

This is a multicenter, retrospective observational study with development and external validation cohorts. The planned enrollment is 1,500 patients overall, with an external validation cohort of 247 used for the primary outcome (macro AUC one-vs-rest for three-class Montreal extent prediction).

Predictors are pre-endoscopic symptoms, signs, and laboratory tests; the model will not use endoscopic findings as inputs. The study is registered as ACTIVE_NOT_RECRUITING and describes nested cross-validation for model development and independent external validation.

The registry record clarifies this is intended as a decision-support tool and explicitly states it is not a replacement for colonoscopy or histopathology.

Keep In Mind

This is a registered observational study (ACTIVE_NOT_RECRUITING) describing planned development and external validation; the registry entry does not report study results, so interpretative claims should await full results and peer review.

Source Details

Review the original publication for the complete reporting, methods, and context.

Read Original Source
Clinical trial Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorBeijing University of Chinese Medicine
Trial IDNCT07721987
Study typeObservational
Enrollment1,500 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedJul 23, 2026, 12:00 AM
Content availableTrial registry record

This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.

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