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NCT05388331Recruiting

RIS International Cohort

The Radiologically Isolated Syndrome International Cohort

Source: ClinicalTrials.gov · Last updated 24 May 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
19 Apr 2022
Start date
15 Apr 2022
Primary completion date
15 Apr 2023
Lead sponsor
Centre Hospitalier Universitaire de Nice
NCT number
NCT05388331

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 15 Apr 2022 to the primary completion date, 15 Apr 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • suspicion of another disease explaining MRI lesions.

Other

  • abnormal neurological exam,

Who the study is looking for

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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nice University Hospital
Coordinator of this site? Confirm its status
NiceFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.