Actively Recruiting

All Genders
ID05154370

China National Registry of Neuro-Inflammatory Diseases: a Prospective Cohort Study

Led by Beijing Tiantan Hospital · Updated on 2023-07-21

10000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Central nervous system idiopathic inflammatory demyelinating diseases (IDD), including multiple sclerosis (MS), clinically isolated syndrome (CIS), neuromyelitis optica spectrum disorder (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), and acute disseminated encephalomyelitis (ADEM), are autoimmune conditions that cause damage in the brain, spinal cord, and optic nerves. This research aims to build a large national registry of Chinese patients with IDD to better understand the natural course, disability progression, and prognosis of these diseases. The study will also explore biological and imaging markers that predict disease progression and treatment effects. This is a prospective, observational, multicenter cohort study that collects detailed clinical, demographic, and medical data from patients diagnosed with IDD according to established criteria. Treatments are not limited by the study and follow current guidelines, including common use of high-dose intravenous steroids during acute stages and immunomodulatory therapies during remission. Data will be gathered regularly over up to five years, including clinical assessments, imaging, and biological tests. Participants will be followed routinely from enrollment, with assessments including relapse rates, disability scores, brain and spinal cord MRI changes, visual acuity tests, retinal nerve fiber thickness, cognitive function, and serum markers. Safety and tolerability will also be monitored. The study plans to enroll 10,000 patients, with continuous data collection to understand long-term treatment outcomes and disease progression in Chinese IDD patients.

CONDITIONS

Brief Title

China National Registry of Neuro-Inflammatory Diseases

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • No restriction on age or sex
  • Diagnosis of at least one idiopathic inflammatory demyelinating disease (CIS, MS, NMOSD, MOGAD, ADEM)
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Severe mental illness preventing cooperation with examinations or follow-up
  • Unable or unwilling to sign informed consent form

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are regularly observed to collect clinical data and assess disease progression and treatment outcomes over time.

Visits at baseline, Month 6, Month 12, and every 6 months up to 5 years including yearly MRI and other assessments

Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100069

Actively Recruiting

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Research Team

F

Fu-Dong Shi

D

Decai Tian

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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