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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04202055
Other study ID # NIMAO/2017-01/ET-01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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