Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis

Recruiting

• Conditions: Multiple Sclerosis

• 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

Study Timeline

• Study Start: 2019-05-22
• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)
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)
Create biobank	2 years	Blood samples
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 d'Amiens; 🇫🇷 Amiens, France

CHU de Besancon; 🇫🇷 Besançon, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Caen; 🇫🇷 Caen, France

CHU de Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

Hopital Henri Mondor; 🇫🇷 Créteil, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de Lille; 🇫🇷 Lille, France

CHU de Limoges; 🇫🇷 Limoges, France

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