NCT05352971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
664

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

April 25, 2022

Last Update Submit

October 6, 2023

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • compare the GFAP values obtained using the ELLA and SIMOA platforms in MS patients

    Day 0

  • to build a "global disease activity score"

    Day 0

  • to build a "global disability score"

    Day 0

Study Arms (1)

Patients with multiple sclerosis

Other: Biomarker quantification

Interventions

Biomarker quantificationOTHER

Patient blood samples will be tested on 2 different platforms

Patients with multiple sclerosis

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Hôpital Henri Mondor

Créteil, France

Location

CHRU Lille

Lille, France

Location

Hospices Civils de Lyon

Lyon, France

Location

CHU Gui de Chauliac

Montpellier, France

Location

CHU de Nantes,

Nantes, France

Location

Centre Hospitalier Universitaire Pasteur 2

Nice, France

Location

CHU de Nîmes

Nîmes, France

Location

Hôpital Pitié-Salpêtrière

Paris, France

Location

CHU de Strasbourg

Strasbourg, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Eric Thouvenot

    CHU de Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

September 15, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

FR(10)