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

NCT03981003 | Recruiting

• 1 other identifier: CIVI/2018/ET-02
• Study Type: observational
• Target: 1,150
• Locations: 2 countries
• Sites: 28

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.

Conditions

Multiple Sclerosis

Keywords

Neurofilament-light chain; Glial fibrillary Acidic Protein (GFAP)

Outcome Measures

Primary Outcomes (13)

• Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  Inclusion

• GFAP level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  Inclusion

• Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  6 months

• GFAP level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  6 months

• Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  12 months

• GFAP level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  12 months

• Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  18 months

• GFAP level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  18 months

• Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  2 years

• GFAP level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  3 years

• GFAP level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  4 years

• GFAP level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  5 years

• GFAP level in patients with evolving disease compared to those with stable disease

  pg/mL; measured by digital ELISA

  6 years

Secondary Outcomes (168)

• 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

• 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

• 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.

  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.

  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.

  1 year

Study Arms (1)

MS Patients

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain and GFAP levels

MS Patients

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of consecutive patients over 15 years of age, of both sexes, recruited during consultations for a CIS, RRMS or progressive MS at the Neurology department of 30 OFSEP centres and of Nîmes and Nantes University Hospitals. The patients recruited will have an EDSS score comprised between 0 - 7.0.

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Hospices Civils de Lyon: collaborator

Study Sites (28)

CHU d'Amiens

Amiens, France

NOT YET RECRUITING

CHU de Besancon

Besançon, France

NOT YET RECRUITING

CHU de Bordeaux

Bordeaux, France

NOT YET RECRUITING

CHU de Caen

Caen, France

NOT YET RECRUITING

CHU de Clermont Ferrand

Clermont-Ferrand, France

NOT YET RECRUITING

Hopital Henri Mondor

Créteil, France

NOT YET RECRUITING

CHU de Dijon

Dijon, France

NOT YET RECRUITING

CHU de Grenoble

Grenoble, France

NOT YET RECRUITING

CHU de Lille

Lille, France

NOT YET RECRUITING

CHU de Limoges

Limoges, France

NOT YET RECRUITING

CHU de Lyon

Lyon, France

NOT YET RECRUITING

Hopital Timone

Marseille, France

NOT YET RECRUITING

CHU de Montpellier

Montpellier, France

NOT YET RECRUITING

CHU de Nancy

Nancy, France

NOT YET RECRUITING

CHU de Nice

Nice, France

NOT YET RECRUITING

CHU de Nimes

Nîmes, 30029, France

RECRUITING

Fondation Rothschild

Paris, France

NOT YET RECRUITING

Hopital Pitie Salpetriere

Paris, France

NOT YET RECRUITING

Hopital Saint Antoine

Paris, France

NOT YET RECRUITING

CH de Poissy

Poissy, France

NOT YET RECRUITING

CHU de Potiers

Potiers, France

NOT YET RECRUITING

CHU de Rennes

Rennes, France

NOT YET RECRUITING

CHU de Rouen

Rouen, France

NOT YET RECRUITING

CHU de Saint Etienne

Saint-Etienne, France

NOT YET RECRUITING

CHU de Strasbourg

Strasbourg, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, France

NOT YET RECRUITING

CHU de Tours

Tours, France

NOT YET RECRUITING

CHU de Martinique

Fort-de-France, Martinique

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Multiple Sclerosis; Charcot-Marie-Tooth disease, Type 1F

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Eric Thouvenot

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Thouvenot

CONTACT

+33.(0)4.66.68.32.61; eric.thouvenot@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 10, 2019
• Study Start: May 22, 2019
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (27); MA (1)