National, Multicentric Registry Study on Neuroimmunological Diseases in China

NCT ID: NCT06443333

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 7000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2024-12-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

neuroimmune diseases patient

Patients diagnosed with neuroimmune diseases by a neurologist.

Data collection and follow-up observation

Intervention Type: 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.

Health Volunteers

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

Data collection

Intervention Type: OTHER

Collect demographic and genetic information from healthy volunteers upon enrollment.

Interventions

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.

Intervention Type: OTHER

Data collection

Collect demographic and genetic information from healthy volunteers upon enrollment.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junwei Hao, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital ,Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Junwei Hao, MD

Role: CONTACT

haojunwei@vip.163.com

01083198277

Facility Contacts

Junwei Hao, MD

Role: primary

haojunwei@vip.163.com

01083198277

Other Identifiers

XWZC20210115

Identifier Type: -

Identifier Source: org_study_id