Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Diagnostic Test: Blood sample
- Registration Number
- NCT03981003
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1150
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MS Patients Blood sample -
- Primary Outcome Measures
Name Time Method GFAP level in patients with evolving disease compared to those with stable disease 6 years pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease 2 years pg/mL; measured by digital ELISA
- Secondary Outcome Measures
Name Time Method Use of Disease Modifying Drugs 2 years Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)
Create biobank 2 years Blood samples
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 18 months pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients 2 year pg/mL; measured by digital ELISA
Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity) 2 years pg/mL; measured by digital ELISA
GFAP level in patients with relapse compared to stable patients 2 years pg/mL; measured by digital ELISA
GFAP level in patients with isolated MRI activity compared to stable patients 6 months 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. 2 years pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients 2 years pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients 2 years pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement 2 years pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion Month 6 pg/mL; measured by digital ELISA
Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion Month 6 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. 2 years pg/mL; measured by digital ELISA
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 2 years pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain level in patients with relapse compared to stable patients 2 years pg/mL; measured by digital ELISA
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients 2 years pg/mL; measured by digital ELISA
Serum GFAP level in patients with isolated MRI activity compared to stable patients 2 years 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 2 years pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity) 2 years pg/mL; measured by digital ELISA
Serum GFAP level in patients with MRI activity 2 years pg/mL; measured by digital ELISA
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement 2 years pg/mL; measured by digital ELISA
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement 2 years pg/mL; measured by digital ELISA
Generic health status active MRI (measured up to 2 years) EuroQol 5 dimension questionnaire (EQ-5D)
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients 2 year 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 2 years 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 2 years pg/mL; measured by digital ELISA
Serum GFAP level in patients with disease activity (relapse or MRI activity) 2 years 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 2 years pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement 2 years 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 2 years pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity) 2 years 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 GFAP level in patients with relapses 2 years pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain level in patients with MRI activity 2 years pg/mL; measured by digital ELISA
Level of disability Relapse (measured up to 2 years) Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis
Severity of multiple sclerosis Active MRI (measured up to 2 years) Multiple Sclerosis Functional Composite
Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients Month 6 pg/mL; measured by digital ELISA
Serum GFAP in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients Month 6 pg/mL; measured by digital ELISA
Trial Locations
- Locations (28)
CHU de Grenoble
🇫🇷Grenoble, France
CHU de Besancon
🇫🇷Besançon, France
CHU de Bordeaux
🇫🇷Bordeaux, France
CHU d'Amiens
🇫🇷Amiens, France
CHU de Clermont Ferrand
🇫🇷Clermont-Ferrand, France
CHU de Dijon
🇫🇷Dijon, France
CHU de Caen
🇫🇷Caen, France
Hopital Henri Mondor
🇫🇷Créteil, France
CHU de Limoges
🇫🇷Limoges, France
CHU de Nimes
🇫🇷Nîmes, France
CHU de Lille
🇫🇷Lille, France
Fondation Rothschild
🇫🇷Paris, France
CHU de Lyon
🇫🇷Lyon, France
Hopital Timone
🇫🇷Marseille, France
CHU de Montpellier
🇫🇷Montpellier, France
Hopital Pitie Salpetriere
🇫🇷Paris, France
CHU de Nancy
🇫🇷Nancy, France
CHU de Rennes
🇫🇷Rennes, France
Hopital Saint Antoine
🇫🇷Paris, France
CH de Poissy
🇫🇷Poissy, France
CHU de Nice
🇫🇷Nice, France
CHU de Potiers
🇫🇷Potiers, France
CHU de Rouen
🇫🇷Rouen, France
CHU de Saint Etienne
🇫🇷Saint-Étienne, France
CHU de Strasbourg
🇫🇷Strasbourg, France
CHU de Toulouse
🇫🇷Toulouse, France
CHU de Tours
🇫🇷Tours, France
CHU de Martinique
🇲🇶Fort-de-France, Martinique