Biomarkers in Autoimmune Disease of Nervous System

NCT ID: NCT06502015

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-31

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autoimmune Diseases of the Nervous System Neuromyelitis Optica Spectrum Disorder Multiple Sclerosis Guillain-Barre Syndrome Acute Disseminated Encephalomyelitis Autoimmune Encephalitis Stiff-Person Syndrome Myasthenia Gravis Chronic Inflammatory Demyelinating Polyradiculoneuropathy Idiopathic Inflammatory Myopathies Autoimmune Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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autoimmune disease

clinical diagnosis with autoimmune disease of central nervous system

biomaker levels

Intervention Type DIAGNOSTIC_TEST

this study will discover and validate novel biomarkers (including blood, feces, bone marrow and lymph nodes etc al) of various neurological autoimmune diseases

health control

age- and sex-matched control individuals

biomaker levels

Intervention Type DIAGNOSTIC_TEST

this study will discover and validate novel biomarkers (including blood, feces, bone marrow and lymph nodes etc al) of various neurological autoimmune diseases

Interventions

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biomaker levels

this study will discover and validate novel biomarkers (including blood, feces, bone marrow and lymph nodes etc al) of various neurological autoimmune diseases

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis with autoinflammatory diseases of the nervous system, including: Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy(IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), ect al.
* sex and age-matched healthy individuals

Exclusion Criteria

* Known history of primary immunodeficiency (innate or acquired).
* Patients with severe central nervous system, pulmonary, or other systemic infections.
* Patients with secondary central nervous system demyelinating lesions, such as those caused 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Daishi Tian

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dai-shi Tian, MD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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

Wuhan, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Luo-qi Zhou, MD

Role: CONTACT

86-27-83663337

Facility Contacts

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Dai-shi Tian, Dr

Role: primary

86-27-83663337

References

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McPherson RC, Anderton SM. Adaptive immune responses in CNS autoimmune disease: mechanisms and therapeutic opportunities. J Neuroimmune Pharmacol. 2013 Sep;8(4):774-90. doi: 10.1007/s11481-013-9453-9. Epub 2013 Apr 9.

Reference Type RESULT
PMID: 23568718 (View on PubMed)

Stenager E. A global perspective on the burden of multiple sclerosis. Lancet Neurol. 2019 Mar;18(3):227-228. doi: 10.1016/S1474-4422(18)30498-8. Epub 2019 Jan 21. No abstract available.

Reference Type RESULT
PMID: 30679041 (View on PubMed)

Solomon AJ, Arrambide G, Brownlee WJ, Flanagan EP, Amato MP, Amezcua L, Banwell BL, Barkhof F, Corboy JR, Correale J, Fujihara K, Graves J, Harnegie MP, Hemmer B, Lechner-Scott J, Marrie RA, Newsome SD, Rocca MA, Royal W 3rd, Waubant EL, Yamout B, Cohen JA. Differential diagnosis of suspected multiple sclerosis: an updated consensus approach. Lancet Neurol. 2023 Aug;22(8):750-768. doi: 10.1016/S1474-4422(23)00148-5.

Reference Type RESULT
PMID: 37479377 (View on PubMed)

Other Identifiers

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TJ-IRB202406068

Identifier Type: -

Identifier Source: org_study_id

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