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

NCT ID: NCT05479617

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-20

Study Completion Date

2026-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Deep learning model

Use of deep learning model to predict individual patients disease course

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Well-founded doubt that the flare is due to other than the patients UC
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role lead

Responsible Party

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Bobby Lo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gastrounit, medical section, Copenhagen University Hospital Hvidovre

Hvidovre, Denmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Bobby ZS Lo, M.D.

Role: primary

+45 28580410

Related Links

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Other Identifiers

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H-21020965

Identifier Type: -

Identifier Source: org_study_id

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