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

Multiple Sclerosis Clinical Trial

— Nf-Ella Loca  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352971
• Other study ID #: CIVI/2021/ET-02
• Status: Completed
• Start date: September 15, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Biomarker quantification
Patient blood samples will be tested on 2 different platforms

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Hôpital Henri Mondor	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-laboratory reproducibility of neurofilament-light chain level measurements	Coefficients of variation will be calculated in 30 patients	Day 0
Primary	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
Primary	Inter-laboratory reproducibility and repeatability of glial fibrillary acidic protein level measurements	Coefficients of variation will be calculated in 30 patients	Day 0
Primary	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	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
Secondary	to build a "global disease activity score"	Logistic regression to predict active multiple sclerosis	Day 0
Secondary	to build a "global disability score"	Logistic regression to predict Expanded Disability Status Scale score	Day 0