Biomarkers in Autoimmune Disease of Nervous System

November 17, 2024 updated by: Daishi Tian, Tongji Hospital

Biomarkers of Neurological Autoimmune Diseases

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Wuhan, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
autoimmune disease
clinical diagnosis with autoimmune disease of central nervous system
Diagnostic test: 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
health control
age- and sex-matched control individuals
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 10 years
Death during the follow-up in every single reason
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Autoimmune disease of any kind
Time Frame: 10 years
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accumulated total active MRI lesions
Time Frame: 10 years
the number of accumulate total active MRI lesions after CT103A infusion
10 years
Expanded Disability Status Scale (EDSS) score
Time Frame: 10 years
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
Visual acuity
Time Frame: 10 years
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)
Time Frame: 10 years
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
Time Frame: 10 years
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
Time Frame: 10 years
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
Time Frame: 10 years
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
Time Frame: 10 years
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
Time Frame: 10 years
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
Time Frame: 10 years
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
Time Frame: 10 years
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
Time Frame: 10 years
such as ferritin, CRP, IL-6 and procalcitonin) will be analyzed
10 years
Profiling of immune cell subtypes
Time Frame: 10 years
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
Modified Rankin Scale
Time Frame: 10 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tongji Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dai-shi Tian, MD, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TJ-IRB202406068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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