Multiple SclerosisNf-Ella LocaNCT05352971
Validation of Ella Platform for Serum Nfl And GFAP Measures In Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Biomarker quantification
- How many people
- 664 participants
- Where
- 10 sitesFrance
- Study dates
- 15 Sep 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with MS from the OFSEP HD (NCT03603457) cohort.
Who may be able to join
- Patients from the OFSEP HD cohort.
- At least one native (no thaw-freeze cycle) serum sample in local or in centralized Biological Resource Center
Who cannot join
- No bio-collection or insufficient sample volume
- No OFSEP minimal sheet at baseline
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Clermont-Ferrand
Clermont-Ferrand
Hôpital Henri Mondor
Créteil
CHRU Lille
Lille
Hospices Civils de Lyon
Lyon
CHU Gui de Chauliac
Montpellier
CHU de Nantes,
Nantes
Centre Hospitalier Universitaire Pasteur 2
Nice
CHU de Nîmes
Nîmes
Hôpital Pitié-Salpêtrière
Paris
CHU de Strasbourg
Strasbourg
About this study
Official title: Multi-Site 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Biomarker quantification
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker quantificationOther
Patient blood samples will be tested on 2 different platforms
| Study group | Role | What they receive |
|---|---|---|
| Patients with multiple sclerosis | Not described Receives: Other: Biomarker quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-laboratory reproducibility of neurofilament-light chain level measurements
Coefficients of variation will be calculated in 30 patients
Measured: 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
Measured: Day 0
Inter-laboratory reproducibility and repeatability of glial fibrillary acidic protein level measurements
Coefficients of variation will be calculated in 30 patients
Measured: 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
Measured: Day 0
Secondary outcomes (3)
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
Measured: Day 0
to build a "global disease activity score"
Logistic regression to predict active multiple sclerosis
Measured: Day 0
to build a "global disability score"
Logistic regression to predict Expanded Disability Status Scale score
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start15 Sep 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Thouvenot, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352971
- Sponsor's protocol ID
- CIVI/2021/ET-02
- Acronym
- Nf-Ella Loca
- Status last verified
- Oct 2023
- First submitted
- 25 Apr 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Site Validation of Ella Platform for Serum Nfl And GFAP Measures In Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05352971
- Acronym / sponsor ID
- Nf-Ella Loca / CIVI/2021/ET-02
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with multiple sclerosis | – | Other: Biomarker quantification |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with MS from the OFSEP HD (NCT03603457) cohort.
Key inclusion criteria (2 listed)
- Patients from the OFSEP HD cohort.
- At least one native (no thaw-freeze cycle) serum sample in local or in centralized Biological Resource Center
Key exclusion criteria (2 listed)
- No bio-collection or insufficient sample volume
- No OFSEP minimal sheet at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker quantificationPatient blood samples will be tested on 2 different platforms | Other | Patients with multiple sclerosis |
Primary outcome
Inter-laboratory reproducibility of neurofilament-light chain level measurements
Time frame: Day 0
Coefficients of variation will be calculated in 30 patients
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
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
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
3 secondary outcomes
compare the GFAP values obtained using the ELLA and SIMOA platforms in MS patients
Time frame: Day 0
to build a "global disease activity score"
Time frame: Day 0
to build a "global disability score"
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Thouvenot principal investigator
CHU de Nimes
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-laboratory reproducibility of neurofilament-light chain level measurements (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.