Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases

NCT ID: NCT06541626

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2035-12-31

Brief Summary

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The goal of this observational study is to learn about pathogenesis and clinical prognosis of CNS IIDD in the Chinese population and to provide evidence-based clues for clinical treatment decisions.

The main questions it aims to answer are:

Question 1: Clarify the clinical characteristics and prognostic factors of various diseases (MS, NMOSD, MOGAD, etc.) within IIDD in the Chinese population.

Question 2: Analyze the relationship between biomarkers and the occurrence, progression, and prognosis of CNS IIDD cases in our hospital.

Participants will

1. Receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus, without additional special interventions.
2. Receive clinical evaluation, follow-up, and management from dedicated neuroimmunology specialists.

Detailed Description

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Conditions

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Multiple Sclerosis, MS Neuromyelitis Optica Spectrum Disorders Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease Acute Disseminated Encephalomyelitis Clinically Isolated Syndrome Demyelinating Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MS

Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.

No interventions assigned to this group

NMOSD

Diagnosis meets the 2015 IPND diagnostic panel standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.

No interventions assigned to this group

MOGAD

Diagnosis meets the 2023 international expert panel recommended standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.

No interventions assigned to this group

ADEM

Diagnosis meets the diagnostic criteria for ADEM

No interventions assigned to this group

CIS

Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.

No interventions assigned to this group

undefined CNS IIDD

First occurrence of CNS inflammatory demyelinating event, not yet diagnosable as MS, NMOSD, MOGAD, ADEM, or other definitive types of central nervous system demyelinating diseases, with symptoms and signs lasting more than 24 hours

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18-65 years with central nervous system idiopathic inflammatory demyelinating diseases (CNS IIDD);
2. The clinical syndrome of the attack meets one of the following: MS, NMOSD, MOGAD, ADEM, clinically isolated syndrome, demyelinating encephalopathy, demyelinating myelitis, or brainstem encephalitis (see below A-E);
3. Agree to participate in this study and sign the informed consent form.

Exclusion Criteria

1. History of tumors or diagnosis of central nervous system tumors;
2. Infectious lesions of the central nervous system;
3. Hereditary, metabolic, toxic, vascular, or traumatic demyelinating diseases of the brain/spinal cord;
4. Non-compliance with treatment and follow-up.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongxuan Wang

Role: CONTACT

86+13824498978

Wanru Chen

Role: CONTACT

86+13242800032

Facility Contacts

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Hongxuan Wang

Role: primary

86-13824498978

Other Identifiers

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SYSKY-2024-109-01

Identifier Type: -

Identifier Source: org_study_id

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