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
Location: See all (5) locations...
Intervention Type: Other
Study Type: Observational
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 and/or 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))

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ The patient must be already included in the OFSEP High Definition cohort (NCT03603457).

• The patient must have given his informed and signed consent for the inclusion in the VHD cohort.

• The patient must be insured or beneficiary of a health insurance plan.

⁃ The healthy subject must be older than 18 years

• The healthy subject must have given his informed and signed consent for the inclusion in the VHD cohort.

• The healthy subject must be insured or beneficiary of a health insurance plan.

Locations
Other Locations
France
CHU de Lyon
NOT_YET_RECRUITING
Lyon
CHU de Nancy
NOT_YET_RECRUITING
Nancy
CHU de Nîmes
NOT_YET_RECRUITING
Nîmes
CHU de Rennes
RECRUITING
Rennes
CHU de Strasbourg
NOT_YET_RECRUITING
Strasbourg
Contact Information
Primary
Anne Kerbrat, Dr
anne.kerbrat@chu-rennes.fr
+33 (0)2 99 28 43 21
Backup
Eric Thouvenot, Pr.
eric.thouvenot@chu-nimes.fr
Time Frame
Start Date: 2023-01-19
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 300
Treatments
Patients with MS
250 patients with MRI, OCT and bio sample
Healthy subjects
50 healthy subjects with MRI
Related Therapeutic Areas
Sponsors
Leads: EDMUS Foundation

This content was sourced from clinicaltrials.gov