Clinical trial NCT05388331: RIS International Cohort
Official title: The Radiologically Isolated Syndrome International Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Radiologically Isolated Syndrome
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects demonstrating white matter T2 lesion suggestive of demyelination, asymptomatic with a normal neurological exam, corresponding to RIS diagnostic criteria.

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* white matter T2 lesions suggestive of demyelination
* asymptomatic
* normal neurological exam

Exclusion Criteria:

* abnormal neurological exam,
* suspicion of another disease explaining MRI lesions.

Primary outcomes:
measure: Identification of lesions T2-weighted sequence at the index scan
timeFrame: at inclusion
measure: Identification of lesions T2-weighted sequence at the index scan
timeFrame: at inclusion
measure: Identification of lesions T1 sequence with and without Gd at the index scan.
timeFrame: at inclusion
measure: Identification of lesions T1 sequence with and without Gd at the index scan.
timeFrame: at inclusion
measure: Radiological progression : new T2 lesions
timeFrame: year 1
measure: Radiological progression : new contrast enhancing lesions
timeFrame: year 1
measure: Radiological progression : new contrast enhancing lesions
timeFrame: year 1
measure: Brain atrophy
timeFrame: year 1
measure: Brain atrophy
timeFrame: year 2
measure: Brain atrophy
timeFrame: year 3
measure: Brain atrophy
timeFrame: year 4
measure: Brain atrophy
timeFrame: year 5
measure: Brain atrophy
timeFrame: MS onset assessed up to 2 years
measure: Radiological progression : new T2 lesions
timeFrame: year 2
measure: Radiological progression : new T2 lesions
timeFrame: year 2
measure: Radiological progression : new T2 lesions
timeFrame: year 3
measure: Radiological progression : new T2 lesions
timeFrame: year 4
measure: Radiological progression : new T2 lesions
timeFrame: year 5
measure: Radiological progression : new T2 lesions
timeFrame: MS onset assessed up to 2 years
measure: Radiological progression : new contrast enhancing lesions
timeFrame: year 2
measure: Radiological progression : new contrast enhancing lesions
timeFrame: year 2
measure: Radiological progression : new contrast enhancing lesions
timeFrame: year 3
measure: Radiological progression : new contrast enhancing lesions
timeFrame: year 3
measure: Radiological progression : new contrast enhancing lesions
timeFrame: year 4
measure: Radiological progression : new contrast enhancing lesions
timeFrame: year 4
measure: Radiological progression : new contrast enhancing lesions
timeFrame: year 5
measure: Radiological progression : new contrast enhancing lesions
timeFrame: year 5
measure: Radiological progression : new contrast enhancing lesions
timeFrame: MS onset assessed up to 2 years
measure: Radiological progression : new contrast enhancing lesions
timeFrame: MS onset assessed up to 2 years
Secondary outcomes:
measure: Collect biological data
timeFrame: At inclusion
measure: Collect biological data
timeFrame: MS onset assessed up to 2 years
measure: Collect digital markers
timeFrame: at inclusion
measure: Collect digital markers
timeFrame: year 1
measure: Collect digital markers
timeFrame: year 2
measure: Collect digital markers
timeFrame: year 3
measure: Collect digital markers
timeFrame: year 4
measure: Collect digital markers
timeFrame: year 5
measure: Collect digital markers
timeFrame: MS onset assessed up to 2 years
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References: