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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Biomarker quantification

• Registration Number: NCT05352971
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-29
• Study Start: 2022-09-15
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with multiple sclerosis	Biomarker quantification	-

Primary Outcome Measures

Name	Time	Method
Inter-laboratory repeatability of neurofilament-light chain level measurements	Day 0	Serum from 3 patients with low, medium or high levels of NfL will be tested 10 times
Inter-laboratory repeatability of glial fibrillary acidic protein level measurements	Day 0	Serum from 3 patients with low, medium or high levels of GFAP will be tested 10 times
Inter-laboratory reproducibility and repeatability of glial fibrillary acidic protein level measurements	Day 0	Coefficients of variation will be calculated in 30 patients
Inter-laboratory reproducibility of neurofilament-light chain level measurements	Day 0	Coefficients of variation will be calculated in 30 patients

Secondary Outcome Measures

Name	Time	Method
compare the GFAP values obtained using the ELLA and SIMOA platforms in MS patients	Day 0	Intraclass concordance correlation coefficient and Passing-Bablock analysis calculated in 210 patients
to build a "global disease activity score"	Day 0	Logistic regression to predict active multiple sclerosis
to build a "global disability score"	Day 0	Logistic regression to predict Expanded Disability Status Scale score

Trial Locations

Locations (10)

Hospices Civils de Lyon; 🇫🇷 Lyon, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHRU Lille; 🇫🇷 Lille, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHU Gui de Chauliac; 🇫🇷 Montpellier, France

CHU de Nantes,; 🇫🇷 Nantes, France

CHU de Nîmes; 🇫🇷 Nîmes, France

Centre Hospitalier Universitaire Pasteur 2; 🇫🇷 Nice, France

CHU de Strasbourg; 🇫🇷 Strasbourg, France

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France