RIS International Cohort

Multiple Sclerosis Clinical Trial

Official title:

The Radiologically Isolated Syndrome International Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05388331
• Other study ID #: 22Neuro01
• Status: Recruiting
• Start date: April 15, 2022
• Est. completion date: April 15, 2029

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Christine LEBNRUN-FRENAY
• Phone: 33 4 92 03 41 26
• Email: lebrun-frenay.c[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 15, 2029
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Radiologically Isolated Syndrome
• Syndrome

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of lesions T2-weighted sequence at the index scan	number of T2-weighted sequence	at inclusion
Primary	Identification of lesions T2-weighted sequence at the index scan	localisation of interest of T2 lesion (juxtacortical, periventricular, infratentorial, spinal cord)	at inclusion
Primary	Identification of lesions T1 sequence with and without Gd at the index scan.	Lesions number	at inclusion
Primary	Identification of lesions T1 sequence with and without Gd at the index scan.	localisation of interest	at inclusion
Primary	Radiological progression : new T2 lesions	localisation of interest	year 1
Primary	Radiological progression : new contrast enhancing lesions	Lesions number	year 1
Primary	Radiological progression : new contrast enhancing lesions	localisation of interest	year 1
Primary	Brain atrophy	measurement of global and regional grey matter volume measurement of global and regional white matter volume	year 1
Primary	Brain atrophy	measurement of global and regional grey matter volume measurement of global and regional white matter volume	year 2
Primary	Brain atrophy	measurement of global and regional grey matter volume measurement of global and regional white matter volume	year 3
Primary	Brain atrophy	measurement of global and regional grey matter volume measurement of global and regional white matter volume	year 4
Primary	Brain atrophy	measurement of global and regional grey matter volume measurement of global and regional white matter volume	year 5
Primary	Brain atrophy	measurement of global and regional grey matter volume measurement of global and regional white matter volume	MS onset assessed up to 2 years
Primary	Radiological progression : new T2 lesions	number of T2-weighted sequence	year 2
Primary	Radiological progression : new T2 lesions	localisation of interest of T2 lesion	year 2
Primary	Radiological progression : new T2 lesions	number of T2-weighted sequence	year 3
Primary	Radiological progression : new T2 lesions	localisation of interest of T2 lesion	year 4
Primary	Radiological progression : new T2 lesions	number of T2-weighted sequence	year 5
Primary	Radiological progression : new T2 lesions	localisation of interest of T2 lesion	MS onset assessed up to 2 years
Primary	Radiological progression : new contrast enhancing lesions	localisation of interest	year 2
Primary	Radiological progression : new contrast enhancing lesions	Lesions number	year 2
Primary	Radiological progression : new contrast enhancing lesions	Lesions number	year 3
Primary	Radiological progression : new contrast enhancing lesions	localisation of interest	year 3
Primary	Radiological progression : new contrast enhancing lesions	Lesions number	year 4
Primary	Radiological progression : new contrast enhancing lesions	localisation of interest	year 4
Primary	Radiological progression : new contrast enhancing lesions	Lesions number	year 5
Primary	Radiological progression : new contrast enhancing lesions	localisation of interest	year 5
Primary	Radiological progression : new contrast enhancing lesions	Lesions number	MS onset assessed up to 2 years
Primary	Radiological progression : new contrast enhancing lesions	localisation of interest	MS onset assessed up to 2 years
Secondary	Collect biological data	number of plasma samples	At inclusion
Secondary	Collect biological data	number of plasma samples	MS onset assessed up to 2 years
Secondary	Collect digital markers	The number of abnormalities identified by the eVOG application correlated with cerebral atrophy	at inclusion
Secondary	Collect digital markers	Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy	year 1
Secondary	Collect digital markers	Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy	year 2
Secondary	Collect digital markers	Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy	year 3
Secondary	Collect digital markers	Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy	year 4
Secondary	Collect digital markers	Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy	year 5
Secondary	Collect digital markers	Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy	MS onset assessed up to 2 years