Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases

NCT06541626 | Recruiting DMC

• 1 other identifier: SYSKY-2024-109-01
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

CNS IIDD; follow-up

Outcome Measures

Primary Outcomes (2)

• Relapse

  Must meet the following criteria：① Appearance of new symptoms or worsening of existing symptoms;② Symptoms attributed to CNS IIDD;③ Duration ≥24 hours;④ Increase in clinical scores (e.g., EDSS);⑤ Imaging or electrophysiological tests clearly showing new responsible lesions.

  Through study completion, an average of 5 years

• Long-term neurological function

  Assessed using the Expanded Disability Status Scale (EDSS)，EDSS score ranges from 0 to 10, with 0 indicating a normal healthy state, 10 indicating death, and higher scores reflecting more severe disability.

  Through study completion, an average of 5 years

Secondary Outcomes (11)

• Long-term neurological function

  Baseline, six months, one year, two years, and average three years

• Sub-scores of the Expanded Disability Status Scale (EDSS)

  Baseline, six months, one year, two years, and average three years

• Optical coherence tomography (OCT) of the eyes: retinal nerve fiber layer thickness, macular thickness

  Baseline, six months, one year, two years, and average three years

• Changes in humoral immune markers

  Baseline, six months, one year, two years, and average three years

• Changes in pathogenic antibody titers

  Baseline, six months, one year, two years, and average three years

Other Outcomes (2)

• Recording of adverse reactions

  Baseline, six months, one year, two years, and average three years

• Follow-up of common adverse reactions

  Baseline, six months, one year, two years, and average three years

Study Arms (6)

MS

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

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.

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.

ADEM

Diagnosis meets the diagnostic criteria for ADEM

CIS

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are aged between 18 and 65 years and diagnosed with central nervous system idiopathic inflammatory demyelinating diseases

You may qualify if:

• Patients aged 18-65 years with central nervous system idiopathic inflammatory demyelinating diseases (CNS IIDD);
• 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);
• Agree to participate in this study and sign the informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease; Encephalomyelitis, Acute Disseminated; Demyelinating Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hongxuan Wang

CONTACT

86+13824498978; wanghx8@mail.sysu.edu.cn

Wanru Chen

CONTACT

86+13242800032; chenwr23@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 7, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)