Immunologic Biomarker Profile of Cerebrospinal Fluid (BIOMOG)
December 16, 2019 updated by: Centre Hospitalier Universitaire de Nīmes
The aim of this study was the describe the Immunologic biomarker profile of cerebrospinal fluid in multiple sclerosis patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
165
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nîmes, France, 30029
- CHU de Nîmes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Samples stored from the NOMADMUS cohort in the OFSEP collection and the NEURO collection from the Centre de Collections Biologiques Hospitalières
Description
Inclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Neuromyelitis optica with anti-MOG
|
Detection of biomarker in cerebrospinal fluid
|
|
Patients with Neuromyelitis optica with anti-AQP4
|
Detection of biomarker in cerebrospinal fluid
|
|
Seronegative patients with Neuromyelitis optica
|
Detection of biomarker in cerebrospinal fluid
|
|
Patients with recurrent-remitting multiple sclerosis
Patients with recurrent-remitting multiple sclerosis with medullary or optic involvement
|
Detection of biomarker in cerebrospinal fluid
|
|
Progressive multiple sclerosis patients
|
Detection of biomarker in cerebrospinal fluid
|
|
Symptomatic controls
|
Detection of biomarker in cerebrospinal fluid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
|
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
|
Baseline
|
|
Level of neurofilament in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Interleukin-6 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Interleukin-8 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
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
|
Baseline
|
|
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
|
Baseline
|
|
Level of Soluble CD27 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Interleukin 10 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Interleukin 17A in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Interleukin 1B in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
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
|
Baseline
|
|
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
|
Baseline
|
|
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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of glial fibrillar acidic protein in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of chitinase-3-like protein 1 in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of neurofilament in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Interleukin-6 in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Interleukin-8 in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of C-X-C motif ligand (CXCL-13) in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Matrix metalloproteinase-9 in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Soluble CD27 in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Interleukin 10 in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Interleukin 17A in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of Interleukin 1B in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of soluble intercellular adhesion molecule-1 in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
|
Level of soluble vascular cell adhesion molecule-1 in cerebrospinal fluid in each group
Time Frame: Baseline
|
enzyme-linked immunosorbent assay
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2018
Primary Completion (Actual)
August 31, 2019
Study Completion (Actual)
August 31, 2019
Study Registration Dates
First Submitted
December 16, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (Actual)
December 17, 2019
Study Record Updates
Last Update Posted (Actual)
December 17, 2019
Last Update Submitted That Met QC Criteria
December 16, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Myelitis, Transverse
- Optic Neuritis
- Multiple Sclerosis
- Neuromyelitis Optica
Other Study ID Numbers
- NIMAO/2017-01/ET-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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