Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05622643
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-10-11
Brief Title:
OFSEP Very High Definition Cohort
Sponsor:
EDMUS Foundation
Organization:
EDMUS Foundation
Study Overview
Official Title:
Very High Definition Cohort Assessment of New Prognostic Biomarkers of Disability Worsening in a Multicenter Cohort of MS Patients by Imaging Optical Coherence Tomography and Biology
Status:
RECRUITING
Status Verified Date:
2024-02
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:
VHD cohort
Brief Summary:
Multiple sclerosis MS is the most common acquired neurological disease leading to disability in young adults MS often leads to the development of a physical andor cognitive impairment that disables patients in their daily lives Early use of disease modifying treatments for patients at risk of developing disability is therefore essential
However disability progression is very heterogeneous between patients and currently impossible to predict at the individual level Thus numerous studies particularly epidemiological and imaging studies have identified prognostic factors for the development of disability such as age gender number of relapses during the first years of the disease existence of a residual disability after a first relapse number of gadolinium-enhancing lesions on initial MRI early brainstem and spinal cord lesions However these different factors only explain incompletely the progression of the physical or cognitive disability in MS patients In particular some components of MS pathophysiology more related to the progressive development of disability such as axonal degeneration or the existence of chronic inflammation of the central nervous system CNS are usually not measured by these biomarkers
In this research project the investigators will test promising biomarkers focused on these components of the disease on a large cohort of patients in a multicenter setting in order to evaluate their added value to predict disability progression in comparison with more classical biomarkers such as clinical characteristics and brain and spinal cord lesion load
In particular the investigators will test
Imaging biomarkers extracted from brain and spinal cord MP2RAGE brain and spinal cord QSM brain and spinal cord relaxometry brain diffusion and spinal cord magnetization transfer sequences
Biomarkers extracted from optical coherence tomography OCT
Biological biomarkers serum neurofilament-light chain NFL and Glial Fibrillary Acidic Protein GFAP
However disability progression is very heterogeneous between patients and currently impossible to predict at the individual level Thus numerous studies particularly epidemiological and imaging studies have identified prognostic factors for the development of disability such as age gender number of relapses during the first years of the disease existence of a residual disability after a first relapse number of gadolinium-enhancing lesions on initial MRI early brainstem and spinal cord lesions However these different factors only explain incompletely the progression of the physical or cognitive disability in MS patients In particular some components of MS pathophysiology more related to the progressive development of disability such as axonal degeneration or the existence of chronic inflammation of the central nervous system CNS are usually not measured by these biomarkers
In this research project the investigators will test promising biomarkers focused on these components of the disease on a large cohort of patients in a multicenter setting in order to evaluate their added value to predict disability progression in comparison with more classical biomarkers such as clinical characteristics and brain and spinal cord lesion load
In particular the investigators will test
Imaging biomarkers extracted from brain and spinal cord MP2RAGE brain and spinal cord QSM brain and spinal cord relaxometry brain diffusion and spinal cord magnetization transfer sequences
Biomarkers extracted from optical coherence tomography OCT
Biological biomarkers serum neurofilament-light chain NFL and Glial Fibrillary Acidic Protein GFAP
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