Validation of Ella Platform for Serum Nfl And GFAP Measures In Multiple Sclerosis Patients (Nf-Ella Loca)

Multi-Site Validation of Ella Platform for Serum Nfl And GFAP Measures In Multiple Sclerosis Patients

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Biomarker quantification

• Study Type: Observational
• Enrollment (Actual): 664

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Chu Clermont-Ferrand
  • Créteil, France
    • Hopital Henri Mondor
  • Lille, France
    • CHRU Lille
  • Lyon, France
    • Hospices Civils de Lyon
  • Montpellier, France
    • CHU Gui de Chauliac
  • Nantes, France
    • CHU de Nantes,
  • Nice, France
    • Centre Hospitalier Universitaire Pasteur 2
  • Nîmes, France
    • CHU de Nîmes
  • Paris, France
    • Hôpital Pitié-Salpêtrière
  • Strasbourg, France
    • CHU de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with MS from the OFSEP HD (NCT03603457) cohort.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with multiple sclerosis	Other: Biomarker quantification; Patient blood samples will be tested on 2 different platforms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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"	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Eric Thouvenot, CHU de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CIVI/2021/ET-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No