Ulcerative ColitisPresager IINCT05479617
Personalised Prediction of Disease Course in Ulcerative Colitis Using Multimodal Machine Learning - Part of the Presager Project
An observational study of Ulcerative Colitis, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Deep learning model
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Jun 2022to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective cohort of a total of 400 UC patients with an active flare
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Gastrounit, medical section, Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650
Bobby ZS Lo, M.D., +45 28580410, bobby.lo@regionh.dk
About this study
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
- Conditions
- Ulcerative Colitis
- Being tested
- Deep learning model
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep learning modelOther
Use of deep learning model to predict individual patients disease course
What is being measured
The primary outcome is the main question the study is designed to answer.
Flare I
Evaluate the accuracy in predicting a flare within 1 year after the patient's initial flare using machine learning methods.
Measured: within 1 year
Secondary outcomes (2)
Flare II
Evaluate the accuracy in predicting a flare within 2 years, after the patient's initial flare, using machine learning methods.
Measured: within 2 years
Flare III
Evaluate the accuracy in predicting a flare within 3 years, after the patient's initial flare, using machine learning methods.
Measured: within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start20 Jun 2022
- Primary completionDec 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bobby Lo, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479617
- Sponsor's protocol ID
- H-21020965
- Acronym
- Presager II
- Status last verified
- Feb 2025
- First submitted
- 29 Jun 2022
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Prediction of Disease Course in Ulcerative Colitis Using Multimodal Machine Learning - Part of the Presager Project
- ClinicalTrials.gov ID
- NCT05479617
- Acronym / sponsor ID
- Presager II / H-21020965
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective cohort of a total of 400 UC patients with an active flare
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep learning modelUse of deep learning model to predict individual patients disease course | Other | – |
Primary outcome
Flare I
Time frame: within 1 year
Evaluate the accuracy in predicting a flare within 1 year after the patient's initial flare using machine learning methods.
2 secondary outcomes
Flare II
Time frame: within 2 years
Flare III
Time frame: within 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- The description is in DanishLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gastrounit, medical section, Copenhagen University Hospital Hvidovre
Hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flare I (time frame: within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.