Personalised Prediction of Disease Course in Ulcerative Colitis Using Multimodal Machine Learning - Part of the Presager Project
Observational · No treatment assigned · 1 site · Copenhagen University Hospital, Hvidovre
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Signed informed consent
- Diagnosis of UC for at least 1 year
- Relapse due to UC.
Plus 2 more requirement(s). Only the trial team can confirm whether you qualify.
What's involved
- About 400 participants are expected to take part.
- Start date: 2022-06-20.
- Main results expected around 2025-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Denmark.
Main thing being measured
- Flare I (within 1 year)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Copenhagen University Hospital, Hvidovre |
| Enrollment | 400 (estimated) |
| Start date | 2022-06-20 |
| Primary completion (est.) | 2025-12 |
| First posted | 2022-07-29 |
| Last updated | 2025-02-27 |
| Official title | Personalised Prediction of Disease Course in Ulcerative Colitis Using Multimodal Machine Learning - Part of the Presager Project |
| ClinicalTrials.gov ID | NCT05479617 |
Interventions
- Deep learning model (Other)
Use of deep learning model to predict individual patients disease course
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Gastrounit, medical section, Copenhagen University Hospital Hvidovre | Hvidovre, Denmark | Denmark | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.