NCT05479617 Personalised Prediction of Disease Course in Ulcerative Colitis Using Multimodal Machine Learning - Part of the Presager Project
| NCT ID | NCT05479617 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Copenhagen University Hospital, Hvidovre |
| Condition | Ulcerative Colitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-06-20 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2022-06-20 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05479617 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05479617 currently recruiting?
Yes, NCT05479617 is actively recruiting participants. Visit ClinicalTrials.gov or contact Copenhagen University Hospital, Hvidovre to inquire about joining.
Where is the NCT05479617 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT05479617 clinical trial?
NCT05479617 is sponsored by Copenhagen University Hospital, Hvidovre. The trial plans to enroll 400 participants.
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