Biomarkers in Autoimmune Disease of Nervous System

NCT06502015 | Recruiting

• 1 other identifier: TJ-IRB202406068
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Biomarker; Autoimmune Diseases of the Nervous System; Immune cell

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Death during the follow-up in every single reason

  10 years

Secondary Outcomes (1)

• Autoimmune disease of any kind

  10 years

Other Outcomes (14)

• Accumulated total active MRI lesions

  10 years

• Expanded Disability Status Scale (EDSS) score

  10 years

• Modified Rankin Scale

  10 years

Study Arms (2)

autoimmune disease

clinical diagnosis with autoimmune disease of central nervous system

Diagnostic Test: biomaker levels

health control

age- and sex-matched control individuals

Diagnostic Test: biomaker levels

Interventions

biomaker levels 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

autoimmune disease; health control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with neurological autoimmune disease admission to Department of Neurology and Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from June 1, 2024 - May 31, 2034.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

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

Wuhan, 430030, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 23568718 RESULT

• 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.

  PMID: 30679041 RESULT

• 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.

  PMID: 37479377 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood, feces, lymph nodes, bone marrow and brain tissue etc.al

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System; Neuromyelitis Optica; Multiple Sclerosis; Guillain-Barre Syndrome; Encephalomyelitis, Acute Disseminated; Stiff-Person Syndrome; Myasthenia Gravis; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Myositis; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Immune System Diseases; Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Polyradiculoneuropathy; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Dai-shi Tian, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luo-qi Zhou, MD

CONTACT

86-27-83663337; zhouluoqi@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 15, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)