National, Multicentric Registry Study on Neuroimmunological Diseases in China

NCT06443333 | Recruiting

• 1 other identifier: XWZC20210115
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to establish a real-world clinical neuroimmune disease research cohort, to follow up and observe the prognosis of patients with different subtypes and subgroups, and to provide support for the treatment, early warning, and outcome prediction research of neuroimmune diseases.

Conditions

Multiple Sclerosis; NMO Spectrum Disorder; Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease; Myasthenia Gravis; Autoimmune Encephalitis; Acute Disseminated Encephalomyelitis

Outcome Measures

Primary Outcomes (1)

• Annual recurrence rate

  Whether there is recurrence in patients followed up at 12 and 24 months after enrollment

  At 12 and 24 months after enrollment

Secondary Outcomes (8)

• Change in Expanded Disability Status Scale scores (EDSS)

  At 6,12,18,24 months after enrollment

• Change in MRI of head, optic nerve and spinal cord

  At 6,12,18,24 months after enrollment

• Change in serum and CSF autoimmune antibody status

  At 6,12,18,24 months after enrollment

• Change in Activity of Daily Living Scale (ADL)

  At 6,12,18,24 months after enrollment

• Change in the relative power spectral density

  At 6,12,18,24 months after enrollment

Study Arms (2)

neuroimmune diseases patient

Patients diagnosed with neuroimmune diseases by a neurologist.

Other: Data collection and follow-up observation

Health Volunteers

Healthy adults undergoing medical examinations at the Xuanwu Hospital Physical Examination Center.

Other: Data collection

Interventions

Data collection and follow-up observation OTHER

At the time of enrollment, the patient's biological samples are collected to obtain genetic information. Following enrollment, trained investigators carry out a 2-year follow-up observation through face-to-face, telephone call or online visits. During the follow-up, basic clinical information, laboratory tests, imaging examinations, neurophysiology, clinical classification, medication use, and scale assessments are collected.

neuroimmune diseases patient

Data collection OTHER

Collect demographic and genetic information from healthy volunteers upon enrollment.

Health Volunteers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and healthy volunteers from China

You may qualify if:

• Patients who diagnosed at Xuanwu Hospital, Capital Medical University with any of the following conditions:
• Multiple Sclerosis (the criteria followed the Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria)
• NMO Spectrum Disorder (the criteria followed the Diagnosis and Treatment Guidelines for Optic Neuromyelitis Spectrum Disorders in China 2016)
• Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (the criteria followed the Consensus of Chinese Experts on Diagnosis and Treatment of Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Diseases)
• Myasthenia Gravis (the criteria followed the Guidelines for the Diagnosis and Treatment of Myasthenia Gravis in China 2020)
• Autoimmune Encephalitis (the criteria followed the China Expert Consensus on Diagnosis and Treatment of Autoimmune Encephalitis 2017)
• Acute Disseminated Encephalomyelitis (the criteria are based on the article titled "Acute disseminated encephalomyelitis" 2007).
• Healthy adults who underwent a physical examination at the Physical Examination Center of Xuanwu Hospital, Capital Medical University

You may not qualify if:

• Women during pregnancy or lactation.
• Patients with other neurological diseases or serious mental diseases.
• Patients with serious liver and kidney function or other important organ dysfunction.
• Unable to cooperate with follow-up work and venous blood collection due to poor compliance of patients or healthy volunteers, or incomplete clinical and imaging data.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital ,Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (1)

• Zhang M, Han J, Xia J, Lin M, Chen T, Ruan S, Wang Q, Men Y, Gao R, Zheng H, Li J, Qi Y, Chen S, Wang Y, Tang Y, Li D, Yang X, Qiu Z, Liu Z, Dong H, Zhao Y, Hao J. Chinese neuroimmunological disease (NIDBase) cohort study: cohort profile. BMJ Open. 2026 Jan 8;16(1):e099386. doi: 10.1136/bmjopen-2025-099386.

  PMID: 41506767 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The biological samples of enrolled patients and healthy volunteers, such as blood and cerebrospinal fluid.

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease; Myasthenia Gravis; Autoimmune Diseases of the Nervous System; Encephalomyelitis, Acute Disseminated

Interventions

Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Junwei Hao, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junwei Hao, MD

CONTACT

01083198277; haojunwei@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: June 5, 2024
• Study Start: December 1, 2020
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)