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

NCT ID: NCT05352971

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

664 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-15

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with multiple sclerosis

Biomarker quantification

Intervention Type OTHER

Patient blood samples will be tested on 2 different platforms

Interventions

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Biomarker quantification

Patient blood samples will be tested on 2 different platforms

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Thouvenot

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Hôpital Henri Mondor

Créteil, , France

Site Status

CHRU Lille

Lille, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

CHU Gui de Chauliac

Montpellier, , France

Site Status

CHU de Nantes,

Nantes, , France

Site Status

Centre Hospitalier Universitaire Pasteur 2

Nice, , France

Site Status

CHU de Nîmes

Nîmes, , France

Site Status

Hôpital Pitié-Salpêtrière

Paris, , France

Site Status

CHU de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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CIVI/2021/ET-02

Identifier Type: -

Identifier Source: org_study_id

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