NCT06443333

National, Multicentric Registry Study on Neuroimmunological Diseases in China

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 7,000 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
OTHER	Data collection	Collect demographic and genetic information from healthy volunteers upon enrollment.

Timeline

• Start date: 2020-12-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2024-06-05
• Last updated: 2024-06-05

Locations

1 site across 1 country: China