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Recruiting NCT05479617

Personalised Prediction of Disease Course in Ulcerative Colitis Using Multimodal Machine Learning - Part of the Presager Project

— Observational Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep learning model.
Who it may be relevant to
Registry conditions: Ulcerative Colitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

In patients achieving clinical remission following a flare, artificial intelligence can reliably predict a new flare within the next 12 months utilizing clinical and objective information at day 0 and week 8. Secondary endpoints: * An artificial intelligence model's precision in predicting a new flare within 2 and 3 years * An artificial intelligence model's precision to rule out patients who will not experience a new flare within 1, 2 and 3 year

Interventions

  • Other Deep learning model
    Use of deep learning model to predict individual patients disease course

Primary outcome measures

  • Flare I [Time frame: within 1 year]
Secondary outcome measures (2)
  • Flare II [Time frame: within 2 years]
  • Flare III [Time frame: within 3 years]

Eligibility criteria

Inclusion criteria

  • Signed informed consent
  • Diagnosis of UC for at least 1 year
  • Relapse due to UC.
  • First endoscopic and histological evaluation of the flare Exclusion criteria
  • Well-founded doubt that the flare is due to other than the patients UC

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Gastrounit, medical section, Copenhagen University Hospital Hvidovre — Hvidovre

Identifiers

NCT: NCT05479617 · H-21020965

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗