Clinical Trial

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

Study acronym: Presager II
Recruiting
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Record status
This record was last updated February 27, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-07-26; most recent amendment 2025-02-25.
Trial Details
NCT Number NCT05479617
Lead Sponsor Copenhagen University Hospital, Hvidovre
Conditions Ulcerative Colitis
Enrollment 400 participants
Start Date 2022-06-20
Primary Completion 2025-12 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-02-27