Immunologic Biomarker Profile of Cerebrospinal Fluid (BIOMOG)

The aim of this study was the describe the Immunologic biomarker profile of cerebrospinal fluid in multiple sclerosis patients

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Neuromyelitis Optica
• Intervention / Treatment: Other: Biomarker analysis

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nîmes

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neuromyelitis optica with anti-MOG	Other: Biomarker analysis; Detection of biomarker in cerebrospinal fluid
Patients with Neuromyelitis optica with anti-AQP4	Other: Biomarker analysis; Detection of biomarker in cerebrospinal fluid
Seronegative patients with Neuromyelitis optica	Other: Biomarker analysis; Detection of biomarker in cerebrospinal fluid
Patients with recurrent-remitting multiple sclerosis; Patients with recurrent-remitting multiple sclerosis with medullary or optic involvement	Other: Biomarker analysis; Detection of biomarker in cerebrospinal fluid
Progressive multiple sclerosis patients	Other: Biomarker analysis; Detection of biomarker in cerebrospinal fluid
Symptomatic controls	Other: Biomarker analysis; 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	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	enzyme-linked immunosorbent assay	Baseline
Level of neurofilament in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Level of Interleukin-6 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Level of Interleukin-8 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	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	enzyme-linked immunosorbent assay	Baseline
Level of Matrix metalloproteinase-9 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Level of Soluble CD27 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Level of Interleukin 10 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Level of Interleukin 17A in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Level of Interleukin 1B in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	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	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	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	enzyme-linked immunosorbent assay	Baseline
Level of chitinase-3-like protein 1 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of neurofilament in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of Interleukin-6 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of Interleukin-8 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of C-X-C motif ligand (CXCL-13) in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of Matrix metalloproteinase-9 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of Soluble CD27 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of Interleukin 10 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of Interleukin 17A in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of Interleukin 1B in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of soluble intercellular adhesion molecule-1 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Level of soluble vascular cell adhesion molecule-1 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

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