Multiple SclerosisAI ProMiSNCT05426980
Artificial Intelligence in Predicting Progression in Multiple Sclerosis Study
An observational study of Multiple Sclerosis and Multiple Sclerosis Lesion, run by University of Ljubljana at 4 sites in Slovenia.
Trial summary
The study proposal focuses on multiple sclerosis (MS), a chronic incurable disease of the central nervous system (CNS). The MS disease is characterised by recurrent transient disability progression, quantified by increase in the extended disability status score (EDSS), and subsequent remission (disappearance of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis Lesion, Multiple Sclerosis Brain Lesion
- How many people
- 654 participants
- Where
- 4 sitesSlovenia
- Study dates
- 13 Dec 2021to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be based on a retrospective secondary analysis of demographic and clinical data and MRI scans of approximately 1200 Slovenian patients with MS that are regularly monitored between 2015 and present.
Who may be able to join
- persons diagnosed with MS (any phenotype; according to the 2010 McDonald criteria) and CIS patients
- availability of at least two MRI exams with both FLAIR and T1-weighted scans of the same participant over a period of at least 6 months at the most recent examination
- availability of demographic, clinical data and treatment information for the same participant over a period of at least 6 months at the most recent examination
- availability of EDSS score and at least one previous EDSS scores for the same participant over a period of at least 6 months at the most recent examination
Who cannot join
- other clinically relevant systemic diseases if the researcher considers them to be significant
Trial locations and contacts
4 sites in 1 country.
Slovenia4 sites
General and teaching hospital Celje
Celje, 3000
General hospital Izola
Izola
University medical center Ljubljana
Ljubljana, Osrednjeslovenska, 1000
University medical center Maribor
Maribor, 2000
About this study
The study proposal focuses on multiple sclerosis (MS), a chronic incurable disease of the central nervous system (CNS). The MS disease is characterised by recurrent transient disability progression, quantified by increase in the extended disability status score (EDSS), and subsequent remission (disappearance of symptoms and reduced EDSS score) or, alternatively, a gradual EDSS disability progression and exacerbation of associated symptoms. At the same time, the MS is characterised by multifocal inflammatory lesions disseminated throughout the white and grey matter of the CNS, which can be observed and quantified in the magnetic resonance (MR) scans. The proposed study will address the critical unmet need of computer-assisted extraction and assessment of prognostic factors based from an individual patient's brain MR scan, such as lesion count, volume, whole-brain and regional brain atrophy, and atrophied lesion volume, in order to evaluate the capability for personalized future disability progression prediction.
- Keywords
- Artificial intelligence, Prediction model, Magnetic resonance imaging, Computer-assisted image analysis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrophied lesion volume derived from MRI predicts confirmed EDSS disability progression
Patients will be divided into two groups based on the presence or absence of EDSS disability progression (DP) during the observation period. The DP converters will be classified as patients with an EDSS change of at least 1.5 if the baseline EDSS is less than 1.0, those with an EDSS change of at least 1.0 if the baseline EDSS is 1.0-5.5, and those with an EDSS change of at least 0.5 if the baseline EDSS is 5.5 or higher [15]. DP converters should have confirmed progression of EDSS impairment over a period of at least 6 months. DP non-converters include individuals who do not meet the criteria for conversion. Atrophied lesion volume will be quantified from MR scans taken >6 months prior to the observed EDSS increase. Advanced artificial intelligence based image analysis tools will be applied to assess the atrophied lesion volume.
Measured: Atrophied lesion volume quantified from two or more MR scans across the span of at least one and up to five years
Secondary outcomes (1)
Atrophied lesion volume derived from MRI predicts conversion to secondary progressive multiple sclerosis
Patients will be divided into two groups, i.e. those who transitioned from clinically isolate syndrome (CIS) or relapsing-remitting (RR) to secondary progressive (SP) form of MS and those who were diagnosed with CIS/RRMS during the observation period. A consilium for patients with MS will confirm the SPMS diagnosis by consensus. Atrophied lesion volume will be quantified from MR scans taken >6 months prior to the observed conversion to the SPMS. Advanced artificial intelligence based image analysis tools will be applied to assess the atrophied lesion volume.
Measured: Atrophied lesion volume quantified from two or more MR scans across the span of least one and up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start13 Dec 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Retrospective
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, General and Teaching Hospital Celje, University Medical Centre Ljubljana, University Medical Centre Maribor, Izola General Hospital
- Responsible party
- Principal investigator, Ziga Spiclin, University of Ljubljana
- Investigators
- Ziga Spiclin, PhD, Principal investigator, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426980
- Sponsor's protocol ID
- 0120-570/2021/5
- Acronym
- AI ProMiS
- Status last verified
- Nov 2023
- First submitted
- 26 May 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence in Predicting Progression in Multiple Sclerosis Study
- ClinicalTrials.gov ID
- NCT05426980
- Acronym / sponsor ID
- AI ProMiS / 0120-570/2021/5
- Keywords
- Artificial intelligence, Prediction model, Magnetic resonance imaging, Computer-assisted image analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Collaborators
- Novartis, General and Teaching Hospital Celje, University Medical Centre Ljubljana, University Medical Centre Maribor, Izola General Hospital
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 22 Jun 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.
The study proposal focuses on multiple sclerosis (MS), a chronic incurable disease of the central nervous system (CNS). The MS disease is characterised by recurrent transient disability progression, quantified by increase in the extended disability status score (EDSS), and subsequent remission (disappearance of symptoms and reduced EDSS score) or, alternatively, a gradual EDSS disability progression and exacerbation of associated symptoms. At the same time, the MS is characterised by multifocal inflammatory lesions disseminated throughout the white and grey matter of the CNS, which can be observed and quantified in the magnetic resonance (MR) scans. The proposed study will address the critical unmet need of computer-assisted extraction and assessment of prognostic factors based from an individual patient's brain MR scan, such as lesion count, volume, whole-brain and regional brain atrophy, and atrophied lesion volume, in order to evaluate the capability for personalized future disability progression prediction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be based on a retrospective secondary analysis of demographic and clinical data and MRI scans of approximately 1200 Slovenian patients with MS that are regularly monitored between 2015 and present.
Key inclusion criteria (4 listed)
- persons diagnosed with MS (any phenotype; according to the 2010 McDonald criteria) and CIS patients
- availability of at least two MRI exams with both FLAIR and T1-weighted scans of the same participant over a period of at least 6 months at the most recent examination
- availability of demographic, clinical data and treatment information for the same participant over a period of at least 6 months at the most recent examination
- availability of EDSS score and at least one previous EDSS scores for the same participant over a period of at least 6 months at the most recent examination
Key exclusion criteria (1 listed)
- other clinically relevant systemic diseases if the researcher considers them to be significant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrophied lesion volume derived from MRI predicts confirmed EDSS disability progression
Time frame: Atrophied lesion volume quantified from two or more MR scans across the span of at least one and up to five years
Patients will be divided into two groups based on the presence or absence of EDSS disability progression (DP) during the observation period. The DP converters will be classified as patients with an EDSS change of at least 1.5 if the baseline EDSS is less than 1.0, those with an EDSS change of at least 1.0 if the baseline EDSS is 1.0-5.5, and those with an EDSS change of at least 0.5 if the baseline EDSS is 5.5 or higher [15]. DP converters should have confirmed progression of EDSS impairment over a period of at least 6 months. DP non-converters include individuals who do not meet the criteria for conversion. Atrophied lesion volume will be quantified from MR scans taken >6 months prior to the observed EDSS increase. Advanced artificial intelligence based image analysis tools will be applied to assess the atrophied lesion volume.
1 secondary outcome
Atrophied lesion volume derived from MRI predicts conversion to secondary progressive multiple sclerosis
Time frame: Atrophied lesion volume quantified from two or more MR scans across the span of least one and up to five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ziga Spiclin, PhD principal investigator
University of Ljubljana
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Multiple Sclerosis Lesion, run by University of Ljubljana at 4 sites in Slovenia.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrophied lesion volume derived from MRI predicts confirmed EDSS disability progression (time frame: Atrophied lesion volume quantified from two or more MR scans across the span of at least one and up to five years). 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 5 Dec 2023.