Multiple Sclerosis
Conditions
Keywords
Neurofilament-light chain, Glial fibrillary Acidic Protein (GFAP)
Brief summary
The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease. In addition, Glial Fibrillary Acidic Protein (GFAP) has also been identified as another serum biomarker of disability in MS.
Interventions
DIAGNOSTIC_TESTBlood sample
2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain and GFAP levels
Sponsors
Hospices Civils de Lyon
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has been correctly informed. * The patient must have given their informed and signed consent. * The patient must be insured or beneficiary of a health insurance plan. * The patient is at least (≥)15 years old. * The patient has MS according to diagnosis criteria (Thompson et al. 2017) and: * Participates to the OFSEP-HD cohort (ancillary study); * Has a Expanded Disability Status Scale score comprised between 0 - 7.0; * With or without Disease Modifying Drug; * For Work Package 3: patients enrolled in any OFSEP-HD centre that meet landmark criteria for an active MS (relapse, or Expanded Disability Status Scale progression, or active MRI) during follow-up; * For Work Package 4: patients with a stable disease enrolled in OFSEP-HD study in Nîmes or Nantes University Hospitals.
Exclusion criteria
* Within the past three months, the patient has participated in another interventional study that may interfere with the results or conclusions of this study. * The patient is in an exclusion period determined by a previous study. * The patient is under judicial protection. * The patient refuses to sign the consent. * It is impossible to correctly inform the patient (inability to understand the study, language problem). * The patient is pregnant or breast-feeding. * The patient is under 15 years old. * Inability to answer questionnaires. * Clinically isolated syndrome (CIS) that does not meet the criteria of MS. * Radiologically isolated syndrome (RIS). * Patient with Neuromyelitis optica spectrum disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease | Inclusion | pg/mL; measured by digital ELISA |
| GFAP level in patients with evolving disease compared to those with stable disease | Inclusion | pg/mL; measured by digital ELISA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients | Inclusion | pg/mL; measured by digital ELISA |
| GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients | Inclusion | pg/mL; measured by digital ELISA |
| GFAP level in patients with relapse compared to stable patients | Inclusion | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with relapse compared to stable patients | 6 months | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients | Inclusion | pg/mL; measured by digital ELISA |
| GFAP level in patients with isolated MRI activity compared to stable patients | Inclusion | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity) | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in patients with isolated MRI activity compared to stable patients | 1 year | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients | Inclusion | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in patients with disease activity (relapse or MRI activity) | Inclusion | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort | Inclusion | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with disease activity (relapse, or MRI activity) | 6 months | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease | Inclusion | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity) | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity) | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in patients with disease activity (relapse, or MRI activity) | 6 months | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with relapses | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in patients with relapses | Inclusion | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with MRI activity | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in patients with MRI activity | Inclusion | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement | Inclusion | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement | Inclusion | pg/mL; measured by digital ELISA |
| Level of disability | Inclusion | Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis |
| Severity of multiple sclerosis | EDSS progression (measured up to 2 years) | Multiple Sclerosis Functional Composite |
| Generic health status | Inclusion | EuroQol 5 dimension questionnaire (EQ-5D) |
| Use of Disease Modifying Drugs | Inclusion | Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies) |
| Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients | Inclusion | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients. | Inclusion | pg/mL; measured by digital ELISA |
| Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion | Inclusion | pg/mL; measured by digital ELISA |
| Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion | Inclusion | pg/mL; measured by digital ELISA |
| Create biobank | Inclusion | Blood samples |
| Serum GFAP in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients | Inclusion | pg/mL; measured by digital ELISA |
| GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients. | Inclusion | pg/mL; measured by digital ELISA |
Countries
France, Martinique
Contacts
Primary ContactEric Thouvenot
Outcome results
None listed