Multiple SclerosisBIOMOGNCT04202055
Immunologic Biomarker Profile of Cerebrospinal Fluid
An observational study of Multiple Sclerosis and Neuromyelitis Optica, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The aim of this study was the describe the Immunologic biomarker profile of cerebrospinal fluid in multiple sclerosis patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Neuromyelitis Optica
- What is being tested?
- Biomarker analysis
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2018to 31 Aug 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Samples stored from the NOMADMUS cohort in the OFSEP collection and the NEURO collection from the Centre de Collections Biologiques Hospitalières
Who may be able to join
- patients who have had neuromyelitis ptica with anti-AQP4 antibodies, or anti- Myelin Oligodendrocyte Glycoprotein antibodies, or double seronegative antibodies.
- Neuromyelitis Optica patients have been prospectively included in the OFSEP collection
- Multiple sclerosis patients, isolated myelitis or optic neuritis patients, and symptomatic controls whose samples will come from the "NEURO" collection of the Hospital Biological Collections Center,
- Patients have given their free consent for use of their samples in research
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was the describe the Immunologic biomarker profile of cerebrospinal fluid in multiple sclerosis patients
- Conditions
- Multiple Sclerosis, Neuromyelitis Optica
- Being tested
- Biomarker analysis
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker analysisOther
Detection of biomarker in cerebrospinal fluid
| Study group | Role | What they receive |
|---|---|---|
| Neuromyelitis optica with anti-MOG | Not described Receives: Other: Biomarker analysis | |
| Patients with Neuromyelitis optica with anti-AQP4 | Not described Receives: Other: Biomarker analysis | |
| Seronegative patients with Neuromyelitis optica | Not described Receives: Other: Biomarker analysis | |
| Patients with recurrent-remitting multiple sclerosis | Patients with recurrent-remitting multiple sclerosis with medullary or optic involvement Receives: Other: Biomarker analysis | |
| Progressive multiple sclerosis patients | Not described Receives: Other: Biomarker analysis | |
| Symptomatic controls | Not described Receives: Other: Biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of glial fibrillar acidic protein in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of chitinase-3-like protein 1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of neurofilament in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Interleukin-6 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Interleukin-8 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of C-X-C motif ligand (CXCL-13) in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Matrix metalloproteinase-9 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Soluble CD27 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Interleukin 10 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Interleukin 17A in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Interleukin 1B in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of soluble intercellular adhesion molecule-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Level of soluble vascular cell adhesion molecule-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
enzyme-linked immunosorbent assay
Measured: Baseline
Secondary outcomes (14)
Level of glial fibrillar acidic protein in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of chitinase-3-like protein 1 in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of neurofilament in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Interleukin-6 in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Interleukin-8 in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of C-X-C motif ligand (CXCL-13) in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Matrix metalloproteinase-9 in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Soluble CD27 in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Interleukin 10 in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Interleukin 17A in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of Interleukin 1B in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of soluble intercellular adhesion molecule-1 in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Level of soluble vascular cell adhesion molecule-1 in cerebrospinal fluid in each group
enzyme-linked immunosorbent assay
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start2 Jan 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
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
- 165 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 Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202055
- Sponsor's protocol ID
- NIMAO/2017-01/ET-01
- Acronym
- BIOMOG
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 17 Dec 2019
- 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 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Biomarker Profile of Cerebrospinal Fluid
- ClinicalTrials.gov ID
- NCT04202055
- Acronym / sponsor ID
- BIOMOG / NIMAO/2017-01/ET-01
- Conditions
- Multiple Sclerosis, Neuromyelitis Optica
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 17 Dec 2019 (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.
The aim of this study was the describe the Immunologic biomarker profile of cerebrospinal fluid in multiple sclerosis patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Neuromyelitis optica with anti-MOG | – | Other: Biomarker analysis |
| Patients with Neuromyelitis optica with anti-AQP4 | – | Other: Biomarker analysis |
| Seronegative patients with Neuromyelitis optica | – | Other: Biomarker analysis |
| Patients with recurrent-remitting multiple sclerosis | – | Other: Biomarker analysisPatients with recurrent-remitting multiple sclerosis with medullary or optic involvement |
| Progressive multiple sclerosis patients | – | Other: Biomarker analysis |
| Symptomatic controls | – | Other: Biomarker analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Samples stored from the NOMADMUS cohort in the OFSEP collection and the NEURO collection from the Centre de Collections Biologiques Hospitalières
Key inclusion criteria (4 listed)
- patients who have had neuromyelitis ptica with anti-AQP4 antibodies, or anti- Myelin Oligodendrocyte Glycoprotein antibodies, or double seronegative antibodies.
- Neuromyelitis Optica patients have been prospectively included in the OFSEP collection
- Multiple sclerosis patients, isolated myelitis or optic neuritis patients, and symptomatic controls whose samples will come from the "NEURO" collection of the Hospital Biological Collections Center,
- Patients have given their free consent for use of their samples in research
Key exclusion criteria (0 listed)
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 analysisDetection of biomarker in cerebrospinal fluid | Other | Neuromyelitis optica with anti-MOG, Patients with Neuromyelitis optica with anti-AQP4, Patients with recurrent-remitting multiple sclerosis, Progressive multiple sclerosis patients, Seronegative patients with Neuromyelitis optica, Symptomatic controls |
Primary outcome
Level of glial fibrillar acidic protein in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of chitinase-3-like protein 1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of neurofilament in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of Interleukin-6 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of Interleukin-8 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of C-X-C motif ligand (CXCL-13) in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of Matrix metalloproteinase-9 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of Soluble CD27 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of Interleukin 10 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of Interleukin 17A in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of Interleukin 1B in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of soluble intercellular adhesion molecule-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
Level of soluble vascular cell adhesion molecule-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time frame: Baseline
enzyme-linked immunosorbent assay
14 secondary outcomes
Level of glial fibrillar acidic protein in cerebrospinal fluid in each group
Time frame: Baseline
Level of chitinase-3-like protein 1 in cerebrospinal fluid in each group
Time frame: Baseline
Level of neurofilament in cerebrospinal fluid in each group
Time frame: Baseline
Level of Interleukin-6 in cerebrospinal fluid in each group
Time frame: Baseline
Level of Interleukin-8 in cerebrospinal fluid in each group
Time frame: Baseline
Level of C-X-C motif ligand (CXCL-13) in cerebrospinal fluid in each group
Time frame: Baseline
Level of Matrix metalloproteinase-9 in cerebrospinal fluid in each group
Time frame: Baseline
Level of Soluble CD27 in cerebrospinal fluid in each group
Time frame: Baseline
Level of Interleukin 10 in cerebrospinal fluid in each group
Time frame: Baseline
Level of Interleukin 17A in cerebrospinal fluid in each group
Time frame: Baseline
Level of Interleukin 1B in cerebrospinal fluid in each group
Time frame: Baseline
Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in each group
Time frame: Baseline
Level of soluble intercellular adhesion molecule-1 in cerebrospinal fluid in each group
Time frame: Baseline
Level of soluble vascular cell adhesion molecule-1 in cerebrospinal fluid in each group
Time frame: Baseline
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 17 Dec 2019.
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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 Nimes
1 site 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 and Neuromyelitis Optica, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 4 inclusion and 0 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Level of glial fibrillar acidic protein in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein (time frame: Baseline). The study lists 14 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 17 Dec 2019.