Ulcerative Colitis Clinical Trial
— Presager IIOfficial title:
Personalised Prediction Of Disease Course In Ulcerative Colitis Using Multimodal Machine Learning - Part Of The Presager Project
NCT number | NCT05479617 |
Other study ID # | H-21020965 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 20, 2022 |
Est. completion date | December 30, 2025 |
Verified date | September 2023 |
Source | Copenhagen University Hospital, Hvidovre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Gastrounit, medical section, Copenhagen University Hospital Hvidovre | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Copenhagen University Hospital, Hvidovre |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Flare II | Evaluate the accuracy in predicting a flare within 2 years, after the patient's initial flare, using machine learning methods. | within 2 years | |
Secondary | Flare III | Evaluate the accuracy in predicting a flare within 3 years, after the patient's initial flare, using machine learning methods. | within 3 years |
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