Immunologic Biomarker Profile of Cerebrospinal Fluid

Multiple Sclerosis Clinical Trial

— BIOMOG  

Official title:

Immunologic Biomarker Profile of Cerebrospinal Fluid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202055
• Other study ID #: NIMAO/2017-01/ET-01
• Status: Completed
• Start date: January 2, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: December 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuromyelitis Optica

Intervention

Other:
• Biomarker analysis
Detection of biomarker in cerebrospinal fluid

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of glial fibrillar acidic protein in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Primary	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
Primary	Level of neurofilament in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Primary	Level of Interleukin-6 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Primary	Level of Interleukin-8 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Primary	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
Primary	Level of Matrix metalloproteinase-9 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Primary	Level of Soluble CD27 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Primary	Level of Interleukin 10 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Primary	Level of Interleukin 17A in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Primary	Level of Interleukin 1B in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Primary	Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein	enzyme-linked immunosorbent assay	Baseline
Primary	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
Primary	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	Level of glial fibrillar acidic protein in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of chitinase-3-like protein 1 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of neurofilament in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of Interleukin-6 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of Interleukin-8 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of C-X-C motif ligand (CXCL-13) in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of Matrix metalloproteinase-9 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of Soluble CD27 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of Interleukin 10 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of Interleukin 17A in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of Interleukin 1B in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of soluble intercellular adhesion molecule-1 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline
Secondary	Level of soluble vascular cell adhesion molecule-1 in cerebrospinal fluid in each group	enzyme-linked immunosorbent assay	Baseline