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

Официальное название

Serum Neurofilament-light Chain and Glial Fibrillary Acidic Proten (GFAP) Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis

Обзор

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.

Вмешательства

• Диагностический тест Blood sample
  2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain and GFAP levels

Первичные конечные точки

• Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [Срок оценки: Inclusion]
• GFAP level in patients with evolving disease compared to those with stable disease [Срок оценки: Inclusion]
• Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [Срок оценки: 6 months]
• GFAP level in patients with evolving disease compared to those with stable disease [Срок оценки: 6 months]
• Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [Срок оценки: 12 months]
• GFAP level in patients with evolving disease compared to those with stable disease [Срок оценки: 12 months]
• Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [Срок оценки: 18 months]
• GFAP level in patients with evolving disease compared to those with stable disease [Срок оценки: 18 months]
• Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease [Срок оценки: 2 years]
• GFAP level in patients with evolving disease compared to those with stable disease [Срок оценки: 3 years]

Вторичные конечные точки (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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 18 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 27 центров

• 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
• … и ещё 19 центров

Martinique · 1 центр

• CHU de Martinique — Fort-de-France

Идентификаторы

NCT: NCT03981003 · CIVI/2018/ET-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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