Clinical trial NCT05352971: Validation of Ella Platform for Serum Nfl And GFAP Measures In Multiple Sclerosis Patients
Official title: Multi-Site Validation of Ella Platform for Serum Nfl And GFAP Measures In Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 664
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MS from the OFSEP HD (NCT03603457) cohort.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients from the OFSEP HD cohort.
* At least one native (no thaw-freeze cycle) serum sample in local or in centralized Biological Resource Center

Exclusion Criteria:

* No bio-collection or insufficient sample volume
* No OFSEP minimal sheet at baseline

Primary outcomes:
measure: Inter-laboratory reproducibility of neurofilament-light chain level measurements
timeFrame: Day 0
measure: Inter-laboratory repeatability of neurofilament-light chain level measurements
timeFrame: Day 0
measure: Inter-laboratory reproducibility and repeatability of glial fibrillary acidic protein level measurements
timeFrame: Day 0
measure: Inter-laboratory repeatability of glial fibrillary acidic protein level measurements
timeFrame: Day 0
Secondary outcomes:
measure: compare the GFAP values obtained using the ELLA and SIMOA platforms in MS patients
timeFrame: Day 0
measure: to build a "global disease activity score"
timeFrame: Day 0
measure: to build a "global disability score"
timeFrame: Day 0
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Montpellier
country: France
facility: CHU Gui de Chauliac
city: Nantes
country: France
facility: CHU de Nantes,
city: Nice
country: France
facility: Centre Hospitalier Universitaire Pasteur 2
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Strasbourg
country: France
facility: CHU de Strasbourg
Study officials:
affiliation: CHU de Nimes
name: Eric Thouvenot
role: PRINCIPAL_INVESTIGATOR
References: