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NCT Number: NCT05388331

RIS 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Radiologically Isolated Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice University Hospital

Nice, 06000, France

Location status: Recruiting

Location contact

Cassandre Landes

CONTACT

[email protected]

Christine Lebrun-Frenay

CONTACT

[email protected]

Christine Lebrun-Frenay

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Identification of lesions T2-weighted sequence at the index scan

    Time frame: at inclusion

    number of T2-weighted sequence

  2. 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)

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

    Time frame: at inclusion

    Lesions number

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

    Time frame: at inclusion

    localisation of interest

  5. Radiological progression : new T2 lesions

    Time frame: year 1

    localisation of interest

  6. Radiological progression : new contrast enhancing lesions

    Time frame: year 1

    Lesions number

  7. Radiological progression : new contrast enhancing lesions

    Time frame: year 1

    localisation of interest

  8. Brain atrophy

    Time frame: year 1

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

  9. Brain atrophy

    Time frame: year 2

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

  10. Brain atrophy

    Time frame: year 3

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

  11. Brain atrophy

    Time frame: year 4

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

  12. Brain atrophy

    Time frame: year 5

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

  13. 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

  14. Radiological progression : new T2 lesions

    Time frame: year 2

    number of T2-weighted sequence

  15. Radiological progression : new T2 lesions

    Time frame: year 2

    localisation of interest of T2 lesion

  16. Radiological progression : new T2 lesions

    Time frame: year 3

    number of T2-weighted sequence

  17. Radiological progression : new T2 lesions

    Time frame: year 4

    localisation of interest of T2 lesion

  18. Radiological progression : new T2 lesions

    Time frame: year 5

    number of T2-weighted sequence

  19. Radiological progression : new T2 lesions

    Time frame: MS onset assessed up to 2 years

    localisation of interest of T2 lesion

  20. Radiological progression : new contrast enhancing lesions

    Time frame: year 2

    localisation of interest

  21. Radiological progression : new contrast enhancing lesions

    Time frame: year 2

    Lesions number

  22. Radiological progression : new contrast enhancing lesions

    Time frame: year 3

    Lesions number

  23. Radiological progression : new contrast enhancing lesions

    Time frame: year 3

    localisation of interest

  24. Radiological progression : new contrast enhancing lesions

    Time frame: year 4

    Lesions number

  25. Radiological progression : new contrast enhancing lesions

    Time frame: year 4

    localisation of interest

  26. Radiological progression : new contrast enhancing lesions

    Time frame: year 5

    Lesions number

  27. Radiological progression : new contrast enhancing lesions

    Time frame: year 5

    localisation of interest

  28. Radiological progression : new contrast enhancing lesions

    Time frame: MS onset assessed up to 2 years

    Lesions number

  29. Radiological progression : new contrast enhancing lesions

    Time frame: MS onset assessed up to 2 years

    localisation of interest

Secondary outcomes

  1. Collect biological data

    Time frame: At inclusion

    number of plasma samples

  2. Collect biological data

    Time frame: MS onset assessed up to 2 years

    number of plasma samples

  3. Collect digital markers

    Time frame: at inclusion

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

  4. Collect digital markers

    Time frame: year 1

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

  5. Collect digital markers

    Time frame: year 2

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

  6. Collect digital markers

    Time frame: year 3

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

  7. Collect digital markers

    Time frame: year 4

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

  8. Collect digital markers

    Time frame: year 5

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

  9. Collect digital markers

    Time frame: MS onset assessed up to 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cassandre LANDES

CONTACT

[email protected]

33 4 92 03 41 26

Christine LEBNRUN-FRENAY

CONTACT

[email protected]

33 4 92 03 41 26

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

The Radiologically Isolated Syndrome International Cohort

Important dates

Study start
2022
Primary completion
2023
Study completion
2029
First posted
May 24, 2022
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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