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

February 25, 2025 updated by: Bobby Lo, Copenhagen University Hospital, Hvidovre

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Gastrounit, medical section, Copenhagen University Hospital Hvidovre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This is a prospective cohort of a total of 400 UC patients with an active flare

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 2 years
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.
within 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital, Hvidovre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-21020965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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