Clinical Trials in France / NCT03981003
Active, not recruiting
Observational
Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis
NCT03981003 · tracked via the Priya Life Science France tracker
Condition(s) studied
Multiple Sclerosis
Investigational drug(s) / intervention(s)
Blood sample
Blood sample: 2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain and GFAP levels
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease — Inclusion
pg/mL; measured by digital ELISA - GFAP level in patients with evolving disease compared to those with stable disease — Inclusion
pg/mL; measured by digital ELISA - Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease — 6 months
pg/mL; measured by digital ELISA - GFAP level in patients with evolving disease compared to those with stable disease — 6 months
pg/mL; measured by digital ELISA - Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease — 12 months
pg/mL; measured by digital ELISA - GFAP level in patients with evolving disease compared to those with stable disease — 12 months
pg/mL; measured by digital ELISA - Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease — 18 months
pg/mL; measured by digital ELISA - GFAP level in patients with evolving disease compared to those with stable disease — 18 months
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 - GFAP level in patients with evolving disease compared to those with stable disease — 3 years
pg/mL; measured by digital ELISA - GFAP level in patients with evolving disease compared to those with stable disease — 4 years
pg/mL; measured by digital ELISA - GFAP level in patients with evolving disease compared to those with stable disease — 5 years
pg/mL; measured by digital ELISA - GFAP level in patients with evolving disease compared to those with stable disease — 6 years
pg/mL; measured by digital ELISA
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| CHU de Lyon | Lyon | France | |
| Hopital Timone | Marseille | France | |
| CHU de Montpellier | Montpellier | France | |
| CHU de Nancy | Nancy | France | |
| CHU de Nice | Nice | France | |
| CHU de Nimes | Nîmes | France | |
| Fondation Rothschild | Paris | France | |
| Hopital Pitie Salpetriere | Paris | France | |
| Hopital Saint Antoine | Paris | France | |
| CH de Poissy | Poissy | France | |
| CHU de Potiers | Potiers | France | |
| CHU de Rennes | Rennes | France | |
| CHU de Rouen | Rouen | France | |
| CHU de Saint Etienne | Saint-Etienne | France | |
| CHU de Strasbourg | Strasbourg | France | |
| CHU de Toulouse | Toulouse | France | |
| CHU de Tours | Tours | France | |
| CHU de Martinique | Fort-de-France | Martinique |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03981003 on ClinicalTrials.gov ↗ ← All trials in France