National, Multicentric Registry Study on Neuroimmunological Diseases in China

Multiple Sclerosis Clinical Trial

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Official title:

National, Multicentric Registry Study on Neuroimmunological Diseases in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443333
• Other study ID #: XWZC20210115
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Xuanwu Hospital, Beijing
• Contact: Junwei Hao, MD
• Phone: 01083198277
• Email: haojunwei[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disseminated Encephalomyelitis
• Autoimmune Diseases of the Nervous System
• Autoimmune Encephalitis
• Encephalitis
• Encephalomyelitis
• Multiple Sclerosis
• Myasthenia Gravis
• Neuromyelitis Optica
• NMO Spectrum Disorder

Intervention

Other:
• Data collection and follow-up observation
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.
• Data collection
Collect demographic and genetic information from healthy volunteers upon enrollment.

Locations

Country	Name	City	State
China	Xuanwu Hospital ,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Expanded Disability Status Scale scores (EDSS)	Change from baseline in Expanded Disability Status Scale scores (EDSS,range from 0 to 10 points, with a higher score indicating a more severe degree of neurological impairment).	At 6,12,18,24 months after enrollment
Secondary	Change in MRI of head, optic nerve and spinal cord	whether there are New or enlarged lesions in T1WI, T2WI, T2 FLAIR, Sag bravo, DTI, and BOLD MRI of head, optic nerve and spinal cord in neuroimmune disease patients.	At 6,12,18,24 months after enrollment
Secondary	Change in serum and CSF autoimmune antibody status	Collect the patient's serum and cerebrospinal fluid to measure the types and concentrations of autoantibodies. Note any changes compared to the baseline.	At 6,12,18,24 months after enrollment
Secondary	Change in Activity of Daily Living Scale (ADL)	Change from baseline in Activity of Daily Living Scale (ADL, range from 14 to 56 points, with higher scores indicating poorer daily life abilities).	At 6,12,18,24 months after enrollment
Secondary	Change in the relative power spectral density	Change from baseline in the relative power spectral density of the delta and theta bands in patients.	At 6,12,18,24 months after enrollment
Secondary	Changes in Symbol Digit Modalities Test (SDMT)	Change from baseline in Symbol Digit Modalities Test (SDMT, scores range from 0 to 110, with lower scores indicating more severe cognitive impairment).	At 6,12,18,24 months after enrollment
Secondary	Changes in Montreal Cognitive Assessment Test (MoCA)	Change from baseline in Montreal Cognitive Assessment Test (MoCA, scores range from 0 to 30, with lower scores indicating more severe cognitive impairment).	At 6,12,18,24 months after enrollment
Secondary	changes in Mini-Mental Status Exam (MMSE)	Change from baseline in Mini-Mental Status Exam (MMSE, scores range from 0 to 30, with lower scores indicating more severe cognitive impairment.)	At 6,12,18,24 months after enrollment