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NCT Number: NCT05479617

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

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

Recruiting

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastrounit, medical section, Copenhagen University Hospital Hvidovre

Hvidovre, Denmark, 2650

Location status: Recruiting

Location contact

Bobby ZS Lo, M.D.

CONTACT

[email protected]

+45 28580410

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep learning model

Other

Use of deep learning model to predict individual patients disease course

Primary outcomes

  1. Flare I

    Time frame: within 1 year

    Evaluate the accuracy in predicting a flare within 1 year after the patient's initial flare using machine learning methods.

Secondary outcomes

  1. Flare II

    Time frame: within 2 years

    Evaluate the accuracy in predicting a flare within 2 years, after the patient's initial flare, using machine learning methods.

  2. Flare III

    Time frame: within 3 years

    Evaluate the accuracy in predicting a flare within 3 years, after the patient's initial flare, using machine learning methods.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Acronym: Presager II

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 29, 2022
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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