Clinical trial NCT06443333: National, Multicentric Registry Study on Neuroimmunological Diseases in China
Official title: National, Multicentric Registry Study on Neuroimmunological Diseases in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
NMO Spectrum Disorder
Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
Myasthenia Gravis
Autoimmune Encephalitis
Acute Disseminated Encephalomyelitis
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 7000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and healthy volunteers from China

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.

Detailed description: The purposes of this study are:(1)Establishing a clinical neuroimmune disease research cohort.(2)Collecting the blood, cerebrospinal fluid and other biological samples of the enrolled patients to discover and detect the new neural antibodies, so as to facilitate the diagnosis of related diseases.(3) Conducting in-depth exploration of the Genetic material of patients with neuroimmune diseases and healthy volunteers with second-generation sequencing technology, discovering the pathogenic genes and the mechanism of disease progression.The enrolled patients will be collected Clinical and therapeutic information. Blood and cerebrospinal fluid from the patients will be collected for sequencing analysis and antibody detection. They will also receive the 2-year follow-up with collection of basic clinical information, cognitive function, EDSS score, etc. Healthy volunteers will have their blood collected for sequencing analysis.

Finish the gene sequencing analysis of blood samples from enrolled patients and healthy volunteers to establish the disease gene database and the reference gene database of the healthy population and find the unique expression quantitative trait loci (eQTL) in China, so as to clarify the pathogenic genes and the key mechanism of neuroimmune disease occurrence and development.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Annual recurrence rate
timeFrame: At 12 and 24 months after enrollment
Secondary outcomes:
measure: Change in Expanded Disability Status Scale scores (EDSS)
timeFrame: At 6,12,18,24 months after enrollment
measure: Change in MRI of head, optic nerve and spinal cord
timeFrame: At 6,12,18,24 months after enrollment
measure: Change in serum and CSF autoimmune antibody status
timeFrame: At 6,12,18,24 months after enrollment
measure: Change in Activity of Daily Living Scale (ADL)
timeFrame: At 6,12,18,24 months after enrollment
measure: Change in the relative power spectral density
timeFrame: At 6,12,18,24 months after enrollment
measure: Changes in Symbol Digit Modalities Test (SDMT)
timeFrame: At 6,12,18,24 months after enrollment
measure: Changes in Montreal Cognitive Assessment Test (MoCA)
timeFrame: At 6,12,18,24 months after enrollment
measure: changes in Mini-Mental Status Exam (MMSE)
timeFrame: At 6,12,18,24 months after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital ,Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Junwei Hao, MD
role: PRINCIPAL_INVESTIGATOR
References: