RIS International Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

white matter T2 lesions suggestive of demyelination

asymptomatic

normal neurological exam

Disqualifiers

abnormal neurological exam,

suspicion of another disease explaining MRI lesions.

Trial population

Subjects demonstrating white matter T2 lesion suggestive of demyelination, asymptomatic with a normal neurological exam, corresponding to RIS diagnostic criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: RIS/1-2 criteria1 intervention
Group B: RIS/3-4 criteria1 intervention
Group C: NON RIS/0 criteria1 intervention

Trial outcomes

Primary outcomes

1

Identification of lesions T2-weighted sequence at the index scan

number of T2-weighted sequence

Time frame
at inclusion
2

Identification of lesions T2-weighted sequence at the index scan

localisation of interest of T2 lesion (juxtacortical, periventricular, infratentorial, spinal cord)

Time frame
at inclusion
3

Identification of lesions T1 sequence with and without Gd at the index scan.

Lesions number

Time frame
at inclusion
4

Identification of lesions T1 sequence with and without Gd at the index scan.

localisation of interest

Time frame
at inclusion

Secondary outcomes

1

Collect biological data

number of plasma samples

Time frame
At inclusion
2

Collect biological data

number of plasma samples

Time frame
MS onset assessed up to 2 years
3

Collect digital markers

The number of abnormalities identified by the eVOG application correlated with cerebral atrophy

Time frame
at inclusion
4

Collect digital markers

Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy

Time frame
year 1

Other outcomes

Sponsors and contacts

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