Biomarkers in Autoimmune Disease of Nervous System
NCT Number: NCT06502015
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
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
Interventions: DIAGNOSTIC_TEST: biomaker levels
Sponsor: Tongji Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2034-06
Locations: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China

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.

Primary Outcome Measures: All-cause mortality, Death during the follow-up in every single reason, 10 years
Secondary Outcome Measures: Autoimmune disease of any kind, Brain or spinal MRI scans will be used to detect the presence of any autoimmune disease, including multiple sclerosis, neuromyelitis optica spectrum disorder, acute disseminated encephalomyelitis, autoimmune encephalitis, Guillain-Barré syndrome, and myasthenia gravis., 10 years
Other Outcome Measures: Accumulated total active MRI lesions, the number of accumulate total active MRI lesions after CT103A infusion, 10 years|Expanded Disability Status Scale (EDSS) score, EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more., 10 years|Modified Rankin Scale, Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. A favorable outcome was characterized as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to 6., 10 years|Visual acuity, Corrected visual acuity is determine by Snellen E chart held at a distance of 5 meters. Higher score indicates better vision., 10 years|Quantitative Myasthenia Gravis Score (QMG), Quantitative Myasthenia Gravis Score (QMG) range from 0 to 3. The normal person scored 0 and the higher score represent sever clinical symptom., 10 years|Myasthenia Gravis Activities if Daily Living (MG-ADL) Score, The MG-ADL is an eight-question survey of symptom severity, with each response graded from 0 (normal) to 3 (most severe). Two questions concern ocular, three oropharyngeal, one respiratory, and two extremity functions. Cumulative MG-ADL scores range from 0 to 24, 10 years|Inflammatory Neuropathy Cause and Treatment (INCAT) Score, The INCAT score comprises two parts, the arm score and the leg score. Based on a patient's level of impairment in their arms and legs, each part is scored between 0 and 5 points, resulting in an INCAT total score between 0 and 10., 10 years|Medical Research Council (MRC) muscle function Score, The MRC score system for testing and grading of muscle function aims to provide a standardized and objective way to assess muscle function. It ranges from 0 to 5., 10 years|Manual Muscle Testing (MMT) Score, For MMT score, 16 muscle groups/ motions will be tested (not individual muscles). 14 of these are tested bilaterally. The score range from 0 to 10. A score of 10 is normal and a score of 0 is the worst., 10 years|36-item Short Form Generic Health Survey (SF-36) score, SF-36 will used to understand the health related quality-of -life of the subjects after CT103A infusion. The eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions will be searched. These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50., 10 years|EuroQol-five dimensions (EQ-SD) score, Health status is measured with the EuroQuality of Life Five Dimensions (EQ-5D) after CT103A infusion, which includes five dimensions and is used to evaluate the quality of life of sepsis survivors. They are mobility, self-care, usual activities, discomfort or pain and depression or anxiety. Levels are coded 1-5 and a total score is then generated. Results for the demographic measured will be displayed as a percentage value., 10 years|Visual analogue scale (VAS) pain score, usual visual analog scale (VAS) of pain is used to evaluate pain after CT103A infusion (line from 0: no pain to 10:worst pain), 10 years|Changes of concentration( pg/mL) of cytokines, such as ferritin, CRP, IL-6 and procalcitonin) will be analyzed, 10 years|Profiling of immune cell subtypes, Changes in immune cells (including proportion of CD3+ T cells, CD3+CD4+ T cells and CD3+CD8+ T cells, ratio of CD4+ T/CD8+T) in blood, CSF and other immune organs will be analyzed through flow cytometry and single cell sequencing., 10 years