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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05479617
Acronym
Presager II
Enrollment
400
Registered
2022-07-29
Start date
2022-06-20
Completion date
2026-07-31
Last updated
2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Brief 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

Interventions

Use of deep learning model to predict individual patients disease course

Sponsors

Copenhagen University Hospital, Hvidovre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Flare Iwithin 1 yearEvaluate the accuracy in predicting a flare within 1 year after the patient's initial flare using machine learning methods.

Secondary

MeasureTime frameDescription
Flare IIwithin 2 yearsEvaluate the accuracy in predicting a flare within 2 years, after the patient's initial flare, using machine learning methods.
Flare IIIwithin 3 yearsEvaluate the accuracy in predicting a flare within 3 years, after the patient's initial flare, using machine learning methods.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026