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Completed

NCT Number: NCT04202055

Immunologic Biomarker Profile of Cerebrospinal Fluid

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomarker Analysis

Other

Detection of biomarker in cerebrospinal fluid

Primary outcomes

  1. 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

  2. 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

  3. Level of neurofilament in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  4. Level of Interleukin-6 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  5. Level of Interleukin-8 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  6. 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

  7. 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

  8. Level of Soluble CD27 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  9. Level of Interleukin 10 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  10. Level of Interleukin 17A in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  11. Level of Interleukin 1B in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  12. 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

  13. 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

  14. 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 outcomes

  1. Level of glial fibrillar acidic protein in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  2. Level of chitinase-3-like protein 1 in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  3. Level of neurofilament in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  4. Level of Interleukin-6 in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  5. Level of Interleukin-8 in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  6. Level of C-X-C motif ligand (CXCL-13) in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  7. Level of Matrix metalloproteinase-9 in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  8. Level of Soluble CD27 in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  9. Level of Interleukin 10 in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  10. Level of Interleukin 17A in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  11. Level of Interleukin 1B in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  12. Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  13. Level of soluble intercellular adhesion molecule-1 in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

  14. Level of soluble vascular cell adhesion molecule-1 in cerebrospinal fluid in each group

    Time frame: Baseline

    enzyme-linked immunosorbent assay

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: BIOMOG

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2019
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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