Recruiting NCT03981003
Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Martinique
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Serum Neurofilament-light Chain and Glial Fibrillary Acidic Proten (GFAP) Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis
Overview
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 test Blood sample
2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain and GFAP levels
Primary outcome measures
- Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [Time frame: Inclusion]
- GFAP level in patients with evolving disease compared to those with stable disease [Time frame: Inclusion]
- Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [Time frame: 6 months]
- GFAP level in patients with evolving disease compared to those with stable disease [Time frame: 6 months]
- Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [Time frame: 12 months]
- GFAP level in patients with evolving disease compared to those with stable disease [Time frame: 12 months]
- Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [Time frame: 18 months]
- GFAP level in patients with evolving disease compared to those with stable disease [Time frame: 18 months]
- Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [Time frame: 2 years]
- GFAP level in patients with evolving disease compared to those with stable disease [Time frame: 3 years]
Secondary outcome measures (12)
- 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. [Time frame: Inclusion]
- 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. [Time frame: Inclusion]
- 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. [Time frame: 6 months]
- 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. [Time frame: 6 months]
- 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. [Time frame: 1 year]
- 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. [Time frame: 3 year]
- 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. [Time frame: 4 year]
- 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. [Time frame: 5 year]
- 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. [Time frame: 6 year]
- 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. [Time frame: 1 year]
- 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. [Time frame: 18 months]
- 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. [Time frame: 18 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 27 centers
- CHU d'Amiens — Amiens
- CHU de Besancon — Besançon
- CHU de Bordeaux — Bordeaux
- CHU de Caen — Caen
- CHU de Clermont Ferrand — Clermont-Ferrand
- Hopital Henri Mondor — Créteil
- CHU de Dijon — Dijon
- CHU de Grenoble — Grenoble
- … and 19 more centers
Martinique · 1 center
- CHU de Martinique — Fort-de-France
Identifiers
NCT: NCT03981003 · CIVI/2018/ET-02