Biomarkers in Autoimmune Disease of Nervous System

Last updated: November 17, 2024
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Polymyositis (Inflammatory Muscle Disease)

Neurologic Disorders

Treatment

biomaker levels

Clinical Study ID

NCT06502015
TJ-IRB202406068
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Neurological autoimmune diseases are a group of disorders characterized by the abnormal immune response attacking the nervous system, including the brain, spinal cord and peripheral nerves. These diseases exhibit high heterogeneity, diverse clinical presentations, and are challenging to diagnose and manage due to a lack of effective treatments. In this study, the investigators will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy (IIM), and multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). Through this study, the investigators aim to discover biomarkers with high sensitivity, specificity, and stability, which can support early diagnosis, disease monitoring, and personalized treatment for neurological autoimmune diseases, thereby improving the quality of life and prognosis for patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis with autoinflammatory diseases of the nervous system, including:Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), ChronicInflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatorymyopathy(IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), MyelinOligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), ect al.

  • sex and age-matched healthy individuals

Exclusion

Exclusion Criteria:

  • Known history of primary immunodeficiency (innate or acquired).

  • Patients with severe central nervous system, pulmonary, or other systemicinfections.

  • Patients with secondary central nervous system demyelinating lesions, such as thosecaused by vasculitis, systemic lupus erythematosus, and Sjögren's syndrome.

  • Patients with vascular (including hemorrhagic and ischemic), hereditary metabolic,neoplastic, or toxic diseases.

  • Pregnant or lactating women.

Study Design

Total Participants: 50000
Treatment Group(s): 1
Primary Treatment: biomaker levels
Phase:
Study Start date:
July 31, 2024
Estimated Completion Date:
July 31, 2027

Study Description

Autoimmune diseases of the nervous system are a type of disease in which the human immune system mistakenly attacks its own nervous system, causing damage to the structure and function of the nervous system. Its main pathogenic mechanism is that autoimmune cells, autoantibodies and other immune molecules directly or indirectly attack the nervous system. Autoimmune diseases of the nervous system can affect the central nervous system, peripheral nervous system and neuromuscular junction, leading to pathological changes such as neuronal or axonal damage, demyelination, and destruction of neuromuscular junction. Autoimmune diseases of the nervous system are relatively rare, with a wide range of damage and complex and diverse clinical manifestations. They have the characteristics of complexity of immune diseases and high mortality and disability of nervous system diseases. At present, the understanding of the disease is limited, and some diseases are difficult to diagnose. Globally, it is a major cause of disability in young and middle-aged people and can cause huge social and economic burdens. However, due to the lack of a series of relatively reliable prognostic predictors, it is impossible to carry out personalized immunotherapy to achieve the best therapeutic effect, and serious adverse events may occur. Proteomics, metabolomics, intestinal microorganisms and intestinal high-throughput targeted metabolomics, exosomes, miRNA sequencing, single-cell transcriptome sequencing and other detection methods and lymphocyte subsets have been hot topics in the study of various diseases in recent years. It has been found that abnormalities in the expression and function of certain genes, proteins, metabolites, miRNAs, intestinal flora and lymphocyte subsets are closely related to the occurrence and development of many diseases and the functional disability of patients, and have a good suggestive effect on prognosis judgment.

Connect with a study center

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430030
    China

    Active - Recruiting

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