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NCT Number: NCT05352971

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomarker quantification

Other

Patient blood samples will be tested on 2 different platforms

Primary outcomes

  1. Inter-laboratory reproducibility of neurofilament-light chain level measurements

    Time frame: Day 0

    Coefficients of variation will be calculated in 30 patients

  2. Inter-laboratory repeatability of neurofilament-light chain level measurements

    Time frame: Day 0

    Serum from 3 patients with low, medium or high levels of NfL will be tested 10 times

  3. Inter-laboratory reproducibility and repeatability of glial fibrillary acidic protein level measurements

    Time frame: Day 0

    Coefficients of variation will be calculated in 30 patients

  4. Inter-laboratory repeatability of glial fibrillary acidic protein level measurements

    Time frame: Day 0

    Serum from 3 patients with low, medium or high levels of GFAP will be tested 10 times

Secondary outcomes

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

    Time frame: Day 0

    Intraclass concordance correlation coefficient and Passing-Bablock analysis calculated in 210 patients

  2. to build a "global disease activity score"

    Time frame: Day 0

    Logistic regression to predict active multiple sclerosis

  3. to build a "global disability score"

    Time frame: Day 0

    Logistic regression to predict Expanded Disability Status Scale score

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: Nf-Ella Loca

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2022
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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