Immunologic Biomarker Profile of Cerebrospinal Fluid

Completed

• Conditions: Neuromyelitis Optica; Multiple Sclerosis
• Interventions: Other: Biomarker analysis

• Registration Number: NCT04202055
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2019-12
• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Last Update Submitted: 2019-12-16
• Study First Posted: 2019-12-17
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Neuromyelitis optica with anti-AQP4	Biomarker analysis	-
Patients with recurrent-remitting multiple sclerosis	Biomarker analysis	Patients with recurrent-remitting multiple sclerosis with medullary or optic involvement
Neuromyelitis optica with anti-MOG	Biomarker analysis	-
Progressive multiple sclerosis patients	Biomarker analysis	-
Symptomatic controls	Biomarker analysis	-
Seronegative patients with Neuromyelitis optica	Biomarker analysis	-

Primary Outcome Measures

Name	Time	Method
Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	Baseline	enzyme-linked immunosorbent assay
Level of glial fibrillar acidic protein in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	Baseline	enzyme-linked immunosorbent assay
Level of neurofilament in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	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	Baseline	enzyme-linked immunosorbent assay
Level of Matrix metalloproteinase-9 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	Baseline	enzyme-linked immunosorbent assay
Level of Soluble CD27 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	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	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	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	Baseline	enzyme-linked immunosorbent assay
Level of Interleukin-6 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	Baseline	enzyme-linked immunosorbent assay
Level of Interleukin-8 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	Baseline	enzyme-linked immunosorbent assay
Level of Interleukin 10 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	Baseline	enzyme-linked immunosorbent assay
Level of Interleukin 17A in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	Baseline	enzyme-linked immunosorbent assay
Level of Interleukin 1B in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	Baseline	enzyme-linked immunosorbent assay

Secondary Outcome Measures

Name	Time	Method
Level of Interleukin 1B in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of soluble intercellular adhesion molecule-1 in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of glial fibrillar acidic protein in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of chitinase-3-like protein 1 in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of C-X-C motif ligand (CXCL-13) in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of Matrix metalloproteinase-9 in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of Interleukin 10 in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of soluble vascular cell adhesion molecule-1 in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of neurofilament in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of Interleukin-6 in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of Interleukin 17A in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of Interleukin-8 in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay
Level of Soluble CD27 in cerebrospinal fluid in each group	Baseline	enzyme-linked immunosorbent assay

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nîmes, France