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Serum neurofilament-light chain (NfL) and glial fibrillary acidic protein (GFAP) measured by single molecule array (SIMOA) are novel biomarkers of multiple sclerosis patients (MS) activity and progression. Its use is limited due to low availability and high costs. ELLA is a cheaper platform with increasing availability. Recently, we compared SIMOA and ELLA platforms to assess serum NfL levels in 203 MS patients from the OFSEP-HD study. There was a strong correlation (Spearman r = 0.86, p < 0.0001) between both platforms. As for SIMOA, serum NfL levels measured by ELLA were correlated with age and EDSS and were significantly higher in active MS, suggesting that these assays are equivalent and can be used in any center for routine care. However, the accuracy of local measures acquired with ELLA has not been determined. The aim os this study is to assess the concordance of multi-site ELLA instruments, accuracy of GFAP measures as compared to SIMOA, and the predictive value of NfL and GFAP measured by ELLA in MS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with multiple sclerosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker quantification | Other | Patient blood samples will be tested on 2 different platforms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inter-laboratory reproducibility of neurofilament-light chain level measurements | Coefficients of variation will be calculated in 30 patients | Day 0 |
| Inter-laboratory repeatability of neurofilament-light chain level measurements | Serum from 3 patients with low, medium or high levels of NfL will be tested 10 times | Day 0 |
| Inter-laboratory reproducibility and repeatability of glial fibrillary acidic protein level measurements | Coefficients of variation will be calculated in 30 patients | Day 0 |
| Inter-laboratory repeatability of glial fibrillary acidic protein level measurements | Serum from 3 patients with low, medium or high levels of GFAP will be tested 10 times | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| compare the GFAP values obtained using the ELLA and SIMOA platforms in MS patients | Intraclass concordance correlation coefficient and Passing-Bablock analysis calculated in 210 patients | Day 0 |
| to build a "global disease activity score" |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with MS from the OFSEP HD (NCT03603457) cohort.
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| Name | Affiliation | Role |
|---|---|---|
| Eric Thouvenot | CHU de Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France | ||||
| Hôpital Henri Mondor |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Logistic regression to predict active multiple sclerosis
| Day 0 |
| to build a "global disability score" | Logistic regression to predict Expanded Disability Status Scale score | Day 0 |
| Créteil |
| France |
| CHRU Lille | Lille | France |
| Hospices Civils de Lyon | Lyon | France |
| CHU Gui de Chauliac | Montpellier | France |
| CHU de Nantes, | Nantes | France |
| Centre Hospitalier Universitaire Pasteur 2 | Nice | France |
| CHU de Nîmes | Nîmes | France |
| Hôpital Pitié-Salpêtrière | Paris | France |
| CHU de Strasbourg | Strasbourg | France |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |