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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06443333
Other study ID # XWZC20210115
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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