Presager II: Personalised Prediction Of Disease Course In Ulcerative Colitis Using Multimodal Machine Learning - Part Of The Presager Project

• Sponsor: Copenhagen University Hospital, Hvidovre (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05479617
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 36.3
• Patients Per Site Per Month: 11

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Other: Deep learning model

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Personalised Prediction Of Disease Course In Ulcerative Colitis Using Multimodal Machine Learning - Part Of The Presager Project
• Actual Study Start Date: Jun 20, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Jun 30, 2025

Outcome Measures

Primary Outcome Measures

1. Flare I [within 1 year]

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

Secondary Outcome Measures

1. Flare II [within 2 years]

   Evaluate the accuracy in predicting a flare within 2 years, after the patient's initial flare, using machine learning methods.

2. Flare III [within 3 years]

   Evaluate the accuracy in predicting a flare within 3 years, after the patient's initial flare, using machine learning methods.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastrounit, medical section, Copenhagen University Hospital Hvidovre	Hvidovre		Denmark	2650

Sponsors and Collaborators

• Copenhagen University Hospital, Hvidovre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The description is in Danish

Publications

None provided.

• Responsible Party: Bobby Lo, Principal Investigator, Copenhagen University Hospital, Hvidovre
• ClinicalTrials.gov Identifier: NCT05479617
• Other Study ID Numbers: H-21020965
• First Posted: Jul 29, 2022
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; Disease Progression

Study Results

No Results Posted as of Jul 29, 2022