Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05388331
Status:
RECRUITING
Last Update Posted:
2022-05-24
First Post:
2022-04-19
Brief Title:
RIS International Cohort
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
The Radiologically Isolated Syndrome International Cohort
Status:
RECRUITING
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 512 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None