Immunologic Biomarker Profile of Cerebrospinal Fluid

Immunologic Biomarker Profile of Cerebrospinal Fluid: Conditions:   Multiple Sclerosis;   Neuromyelitis Optica Intervention:   Other: Biomarker analysis Sponsor:   Centre Hospitalier Universitaire de Nīmes Completed (Source: ClinicalTrials.gov)




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Immunologic Biomarker Profile of Cerebrospinal Fluid (BIOMOG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.



ClinicalTrials.gov Identifier: NCT04202055

Recruitment Status  : Completed

First Posted  : December 17, 2019

Last Update Posted  : December 17, 2019

Sponsor:

Centre Hospitalier Universitaire de Nīmes

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Nīmes



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

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Brief Summary:

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



Condition or disease Intervention/treatment

Multiple Sclerosis

Neuromyelitis Optica

Other: Biomarker analysis



Study Design

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Study Type  : Observational

Actual Enrollment  : 165 participants

Observational Model: Cohort

Time Perspective: Retrospective

Official Title: Immunologic Biomarker Profile of Cerebrospinal Fluid

Actual Study Start Date  : January 2, 2018

Actual Primary Completion Date  : August 31, 2019

Actual Study Completion Date  : August 31, 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Multiple sclerosis Neuromyelitis optica

MedlinePlus related topics: Multiple Sclerosis

Genetic and Rare Diseases Information Center resources: Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Myelitis Optic Neuritis

U.S. FDA Resources



Groups and Cohorts

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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







Outcome Measures

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Primary Outcome Measures  :

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



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



Level of neurofilament in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Interleukin-6 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Interleukin-8 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein [ Time Frame: 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 [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



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



Level of Soluble CD27 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Interleukin 10 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Interleukin 17A in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Interleukin 1B in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



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



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



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





Secondary Outcome Measures  :

Level of glial fibrillar acidic protein in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of chitinase-3-like protein 1 in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of neurofilament in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Interleukin-6 in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Interleukin-8 in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of C-X-C motif ligand (CXCL-13) in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Matrix metalloproteinase-9 in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Soluble CD27 in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Interleukin 10 in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Interleukin 17A in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of Interleukin 1B in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of soluble intercellular adhesion molecule-1 in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay



Level of soluble vascular cell adhesion molecule-1 in cerebrospinal fluid in each group [ Time Frame: Baseline ]

enzyme-linked immunosorbent assay





Eligibility Criteria

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.





Ages Eligible for Study:  Child, Adult, Older Adult

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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

Criteria

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

Contacts and Locations

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.



Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04202055





Locations

France

CHU de Nimes

Nîmes, France, 30029

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator: Eric Thouvenot CHU Nimes

More Information

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Responsible Party: Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier: NCT04202055     History of Changes

Other Study ID Numbers: NIMAO/2017-01/ET-01

First Posted: December 17, 2019    Key Record Dates

Last Update Posted: December 17, 2019

Last Verified: December 2019

Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Sclerosis

Neuromyelitis Optica

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Nervous System Diseases

Demyelinating Diseases

Autoimmune Diseases

Immune System Diseases

Myelitis, Transverse

Optic Neuritis

Optic Nerve Diseases

Cranial Nerve Diseases

Eye Diseases





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