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

NCT05479617 | Recruiting

• 1 other identifier: H-21020965
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Flare I

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

  within 1 year

Secondary Outcomes (2)

• Flare II

  within 2 years

• Flare III

  within 3 years

Interventions

Deep learning model OTHER

Use of deep learning model to predict individual patients disease course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Signed informed consent
• Diagnosis of UC for at least 1 year
• Relapse due to UC.

You may not qualify if:

• Well-founded doubt that the flare is due to other than the patients UC

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Gastrounit, medical section, Copenhagen University Hospital Hvidovre

Hvidovre, Denmark, 2650, Denmark

RECRUITING

Related Links

• The description is in Danish

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 29, 2022
• Study Start: June 20, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

DK (1)