Multiple SclerosisNCT05388331
RIS International Cohort
An observational study of Multiple Sclerosis and Radiologically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The Radiologically Isolated Syndrome (RIS) corresponds to the discovery of white matter (WM) abnormalities suggestive of multiple sclerosis (MS) by their location, size, and appearance, on the brain or spinal cord Magnetic Resonance Imaging (MRI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Radiologically Isolated Syndrome
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2022to 15 Apr 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects demonstrating white matter T2 lesion suggestive of demyelination, asymptomatic with a normal neurological exam, corresponding to RIS diagnostic criteria.
Who may be able to join
- white matter T2 lesions suggestive of demyelination
- asymptomatic
- normal neurological exam
Who cannot join
- abnormal neurological exam,
- suspicion of another disease explaining MRI lesions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nice University Hospital
Nice, 06000
Christine Lebrun-Frenay, lebrun-frenay.c@chu-nice.fr
Cassandre Landes, landes.c@chu-nice.fr
About this study
Official title: The Radiologically Isolated Syndrome International Cohort
The Radiologically Isolated Syndrome (RIS) corresponds to the discovery of white matter (WM) abnormalities suggestive of multiple sclerosis (MS) by their location, size, and appearance, on the brain or spinal cord Magnetic Resonance Imaging (MRI). This imaging is performed for a reason other than for suspicion of demyelinating disease in subjects without a history of neurological symptoms and a strict routine clinical neurological examination. It was defined and named in 2009 (Okuda et al.) after publishing 3 case series (French, USA, Turkey). The Radiologically Isolated Syndrome Consortium (RISC) published a cohort of subjects with an extended follow-up after the first brain MRI of MS, with 34% presenting an event (clinical conversion) at five years, 51.2 % of these subjects showed an event at ten years. The patients who offer a higher risk of developing a first clinical demyelinating event were identified such as male sex, young age, the presence of oligoclonal bands (BOCs) in the Cerebrospinal Fluid (CSF), the presence of infratentorial lesions and spinal cord lesions on the first MRI suggestive of RIS. The location and morphology of the lesions appear to be decisive for studying the risk of conversion. Our first objective is to prospectively collect data to identify the subjects who present a higher risk of developing a first clinical demyelinating event and the progression of the disease in these subjects.
Among the objectives of this worldwide cohort is the analysis of (1) environmental factors (Vit D, EBV, tobacco…), (2) MRI biomarkers, including atrophy, central veins signs, paramagnetic rings, and DTI.
(3) digital biomarkers (4) oculography (5) biological markers To summarize, this cohort will allow for analyzing features in imaging, biology and the exploration of digital and oculographic characteristics to identify predictive factors of clinical evolution of a large cohort of subjects presenting WM abnormalities suggestive of multiple sclerosis.
- Being tested
- No intervention
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| RIS/1-2 criteria | Not described Receives: Other: No intervention | |
| RIS/3-4 criteria | Not described Receives: Other: No intervention | |
| NON RIS/0 criteria | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of lesions T2-weighted sequence at the index scan
number of T2-weighted sequence
Measured: at inclusion
Identification of lesions T2-weighted sequence at the index scan
localisation of interest of T2 lesion (juxtacortical, periventricular, infratentorial, spinal cord)
Measured: at inclusion
Identification of lesions T1 sequence with and without Gd at the index scan.
Lesions number
Measured: at inclusion
Identification of lesions T1 sequence with and without Gd at the index scan.
localisation of interest
Measured: at inclusion
Radiological progression : new T2 lesions
localisation of interest
Measured: year 1
Radiological progression : new contrast enhancing lesions
Lesions number
Measured: year 1
Radiological progression : new contrast enhancing lesions
localisation of interest
Measured: year 1
Brain atrophy
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Measured: year 1
Brain atrophy
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Measured: year 2
Brain atrophy
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Measured: year 3
Brain atrophy
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Measured: year 4
Brain atrophy
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Measured: year 5
Brain atrophy
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Measured: MS onset assessed up to 2 years
Radiological progression : new T2 lesions
number of T2-weighted sequence
Measured: year 2
Radiological progression : new T2 lesions
localisation of interest of T2 lesion
Measured: year 2
Radiological progression : new T2 lesions
number of T2-weighted sequence
Measured: year 3
Radiological progression : new T2 lesions
localisation of interest of T2 lesion
Measured: year 4
Radiological progression : new T2 lesions
number of T2-weighted sequence
Measured: year 5
Radiological progression : new T2 lesions
localisation of interest of T2 lesion
Measured: MS onset assessed up to 2 years
Radiological progression : new contrast enhancing lesions
localisation of interest
Measured: year 2
Radiological progression : new contrast enhancing lesions
Lesions number
Measured: year 2
Radiological progression : new contrast enhancing lesions
Lesions number
Measured: year 3
Radiological progression : new contrast enhancing lesions
localisation of interest
Measured: year 3
Radiological progression : new contrast enhancing lesions
Lesions number
Measured: year 4
Radiological progression : new contrast enhancing lesions
localisation of interest
Measured: year 4
Radiological progression : new contrast enhancing lesions
Lesions number
Measured: year 5
Radiological progression : new contrast enhancing lesions
localisation of interest
Measured: year 5
Radiological progression : new contrast enhancing lesions
Lesions number
Measured: MS onset assessed up to 2 years
Radiological progression : new contrast enhancing lesions
localisation of interest
Measured: MS onset assessed up to 2 years
Secondary outcomes (9)
Collect biological data
number of plasma samples
Measured: At inclusion
Collect biological data
number of plasma samples
Measured: MS onset assessed up to 2 years
Collect digital markers
The number of abnormalities identified by the eVOG application correlated with cerebral atrophy
Measured: at inclusion
Collect digital markers
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
Measured: year 1
Collect digital markers
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
Measured: year 2
Collect digital markers
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
Measured: year 3
Collect digital markers
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
Measured: year 4
Collect digital markers
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
Measured: year 5
Collect digital markers
Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
Measured: MS onset assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start15 Apr 2022
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Apr 2029 (estimated)
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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388331
- Sponsor's protocol ID
- 22Neuro01
- Status last verified
- May 2022
- First submitted
- 19 Apr 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- 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 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Radiologically Isolated Syndrome International Cohort
- ClinicalTrials.gov ID
- NCT05388331
- Acronym / sponsor ID
- 22Neuro01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Apr 2029 (estimated)
- First posted
- 24 May 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 Radiologically Isolated Syndrome (RIS) corresponds to the discovery of white matter (WM) abnormalities suggestive of multiple sclerosis (MS) by their location, size, and appearance, on the brain or spinal cord Magnetic Resonance Imaging (MRI). This imaging is performed for a reason other than for suspicion of demyelinating disease in subjects without a history of neurological symptoms and a strict routine clinical neurological examination. It was defined and named in 2009 (Okuda et al.) after publishing 3 case series (French, USA, Turkey). The Radiologically Isolated Syndrome Consortium (RISC) published a cohort of subjects with an extended follow-up after the first brain MRI of MS, with 34% presenting an event (clinical conversion) at five years, 51.2 % of these subjects showed an event at ten years. The patients who offer a higher risk of developing a first clinical demyelinating event were identified such as male sex, young age, the presence of oligoclonal bands (BOCs) in the Cerebrospinal Fluid (CSF), the presence of infratentorial lesions and spinal cord lesions on the first MRI suggestive of RIS. The location and morphology of the lesions appear to be decisive for studying the risk of conversion. Our first objective is to prospectively collect data to identify the subjects who present a higher risk of developing a first clinical demyelinating event and the progression of the disease in these subjects.
Among the objectives of this worldwide cohort is the analysis of (1) environmental factors (Vit D, EBV, tobacco…), (2) MRI biomarkers, including atrophy, central veins signs, paramagnetic rings, and DTI.
(3) digital biomarkers (4) oculography (5) biological markers To summarize, this cohort will allow for analyzing features in imaging, biology and the exploration of digital and oculographic characteristics to identify predictive factors of clinical evolution of a large cohort of subjects presenting WM abnormalities suggestive of multiple sclerosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RIS/1-2 criteria | – | Other: No intervention |
| RIS/3-4 criteria | – | Other: No intervention |
| NON RIS/0 criteria | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects demonstrating white matter T2 lesion suggestive of demyelination, asymptomatic with a normal neurological exam, corresponding to RIS diagnostic criteria.
Key inclusion criteria (3 listed)
- white matter T2 lesions suggestive of demyelination
- asymptomatic
- normal neurological exam
Key exclusion criteria (2 listed)
- abnormal neurological exam,
- suspicion of another disease explaining MRI lesions.
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 |
|---|---|---|
| No interventionNo intervention | Other | NON RIS/0 criteria, RIS/1-2 criteria, RIS/3-4 criteria |
Primary outcome
Identification of lesions T2-weighted sequence at the index scan
Time frame: at inclusion
number of T2-weighted sequence
Identification of lesions T2-weighted sequence at the index scan
Time frame: at inclusion
localisation of interest of T2 lesion (juxtacortical, periventricular, infratentorial, spinal cord)
Identification of lesions T1 sequence with and without Gd at the index scan.
Time frame: at inclusion
Lesions number
Identification of lesions T1 sequence with and without Gd at the index scan.
Time frame: at inclusion
localisation of interest
Radiological progression : new T2 lesions
Time frame: year 1
localisation of interest
Radiological progression : new contrast enhancing lesions
Time frame: year 1
Lesions number
Radiological progression : new contrast enhancing lesions
Time frame: year 1
localisation of interest
Brain atrophy
Time frame: year 1
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Brain atrophy
Time frame: year 2
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Brain atrophy
Time frame: year 3
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Brain atrophy
Time frame: year 4
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Brain atrophy
Time frame: year 5
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Brain atrophy
Time frame: MS onset assessed up to 2 years
measurement of global and regional grey matter volume measurement of global and regional white matter volume
Radiological progression : new T2 lesions
Time frame: year 2
number of T2-weighted sequence
Radiological progression : new T2 lesions
Time frame: year 2
localisation of interest of T2 lesion
Radiological progression : new T2 lesions
Time frame: year 3
number of T2-weighted sequence
Radiological progression : new T2 lesions
Time frame: year 4
localisation of interest of T2 lesion
Radiological progression : new T2 lesions
Time frame: year 5
number of T2-weighted sequence
Radiological progression : new T2 lesions
Time frame: MS onset assessed up to 2 years
localisation of interest of T2 lesion
Radiological progression : new contrast enhancing lesions
Time frame: year 2
localisation of interest
Radiological progression : new contrast enhancing lesions
Time frame: year 2
Lesions number
Radiological progression : new contrast enhancing lesions
Time frame: year 3
Lesions number
Radiological progression : new contrast enhancing lesions
Time frame: year 3
localisation of interest
Radiological progression : new contrast enhancing lesions
Time frame: year 4
Lesions number
Radiological progression : new contrast enhancing lesions
Time frame: year 4
localisation of interest
Radiological progression : new contrast enhancing lesions
Time frame: year 5
Lesions number
Radiological progression : new contrast enhancing lesions
Time frame: year 5
localisation of interest
Radiological progression : new contrast enhancing lesions
Time frame: MS onset assessed up to 2 years
Lesions number
Radiological progression : new contrast enhancing lesions
Time frame: MS onset assessed up to 2 years
localisation of interest
9 secondary outcomes
Collect biological data
Time frame: At inclusion
Collect biological data
Time frame: MS onset assessed up to 2 years
Collect digital markers
Time frame: at inclusion
Collect digital markers
Time frame: year 1
Collect digital markers
Time frame: year 2
Collect digital markers
Time frame: year 3
Collect digital markers
Time frame: year 4
Collect digital markers
Time frame: year 5
Collect digital markers
Time frame: MS onset assessed up to 2 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 24 May 2022.
- 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.
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 Multiple Sclerosis and Radiologically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 3 inclusion and 2 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 24 May 2022. 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 France. 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?
Contact Christine LEBNRUN-FRENAY (33 4 92 03 41 26, lebrun-frenay.c@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of lesions T2-weighted sequence at the index scan (time frame: at inclusion). The study lists 29 primary outcomes in all. 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 24 May 2022; AzTrials last refreshed its copy on 27 Oct 2026.