RIS International Cohort

NCT05388331 | Recruiting

• 1 other identifier: 22Neuro01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Radiologically Isolated Syndrome

Outcome Measures

Primary Outcomes (29)

• Identification of lesions T2-weighted sequence at the index scan

  number of T2-weighted sequence

  at inclusion

• Identification of lesions T2-weighted sequence at the index scan

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

  at inclusion

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

  Lesions number

  at inclusion

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

  localisation of interest

  at inclusion

• Radiological progression : new T2 lesions

  localisation of interest

  year 1

• Radiological progression : new contrast enhancing lesions

  Lesions number

  year 1

• Radiological progression : new contrast enhancing lesions

  localisation of interest

  year 1

• Brain atrophy

  measurement of global and regional grey matter volume measurement of global and regional white matter volume

  year 1

• Brain atrophy

  measurement of global and regional grey matter volume measurement of global and regional white matter volume

  year 2

• Brain atrophy

  measurement of global and regional grey matter volume measurement of global and regional white matter volume

  year 3

• Brain atrophy

  measurement of global and regional grey matter volume measurement of global and regional white matter volume

  year 4

• Brain atrophy

  measurement of global and regional grey matter volume measurement of global and regional white matter volume

  year 5

• 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

• Radiological progression : new T2 lesions

  number of T2-weighted sequence

  year 2

• Radiological progression : new T2 lesions

  localisation of interest of T2 lesion

  year 2

• Radiological progression : new T2 lesions

  number of T2-weighted sequence

  year 3

• Radiological progression : new T2 lesions

  localisation of interest of T2 lesion

  year 4

• Radiological progression : new T2 lesions

  number of T2-weighted sequence

  year 5

• Radiological progression : new T2 lesions

  localisation of interest of T2 lesion

  MS onset assessed up to 2 years

• Radiological progression : new contrast enhancing lesions

  localisation of interest

  year 2

• Radiological progression : new contrast enhancing lesions

  Lesions number

  year 2

• Radiological progression : new contrast enhancing lesions

  Lesions number

  year 3

• Radiological progression : new contrast enhancing lesions

  localisation of interest

  year 3

• Radiological progression : new contrast enhancing lesions

  Lesions number

  year 4

• Radiological progression : new contrast enhancing lesions

  localisation of interest

  year 4

• Radiological progression : new contrast enhancing lesions

  Lesions number

  year 5

• Radiological progression : new contrast enhancing lesions

  localisation of interest

  year 5

• Radiological progression : new contrast enhancing lesions

  Lesions number

  MS onset assessed up to 2 years

• Radiological progression : new contrast enhancing lesions

  localisation of interest

  MS onset assessed up to 2 years

Secondary Outcomes (9)

• Collect biological data

  At inclusion

• Collect biological data

  MS onset assessed up to 2 years

• Collect digital markers

  at inclusion

• Collect digital markers

  year 1

• Collect digital markers

  year 2

Study Arms (3)

RIS/1-2 criteria

Other: No intervention

RIS/3-4 criteria

Other: No intervention

NON RIS/0 criteria

Other: No intervention

Interventions

No intervention OTHER

No intervention

NON RIS/0 criteria; RIS/1-2 criteria; RIS/3-4 criteria

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma, tears, CSF

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Christine LEBNRUN-FRENAY

CONTACT

33 4 92 03 41 26; lebrun-frenay.c@chu-nice.fr

Cassandre LANDES

CONTACT

33 4 92 03 41 26; landes.c@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 24, 2022
• Study Start: April 15, 2022
• Primary Completion: April 15, 2023
• Study Completion (Estimated): April 15, 2029
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)