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Clinic Registry Study of Optic Neuromyelitis Spectrum Disease in China

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ClinicalTrials.gov Identifier: NCT03514030
Recruitment Status : Enrolling by invitation
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Beijing Tongren Hospital

Brief Summary:
In 1894, Devic first proposed the concept of neuromyelitis optica(NMO). NMO is an inflammatory demyelinating disease that selectively affects the central nervous system of the optic nerve and spinal cord.In 2004, Lennon and other persons found highly specific AQP4(aquaporin 4)antibodies in NMO patients'sera, and further differentiated between NMO and MS, confirming that NMO is an independent disease.At present, NMO has been widely recognized as an idiopathic and severe demyelinating disease of the central nervous system.In 2015, the international NMO diagnostic team developed the diagnostic criteria based on highly specific AQP4 antibodie.Up to now, in China, there is no data on the number of NMOSD patients, the rate of misdiagnosis, the treatment methods, and the prognosis.This study is committed to build China's NMOSD big data platform to provide the basis for diagnosis, treatment and prognosis of the disease.

Condition or disease Intervention/treatment
NMO Spectrum Disorder;Registry Study Diagnostic Test: serum AQP4-antibody testing method

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Clinic Registry Study of Optic Neuromyelitis Spectrum Disease in China
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021


Group/Cohort Intervention/treatment
positive
serum AQP4-antibody is positive
Diagnostic Test: serum AQP4-antibody testing method
there are different methods of testing serum AQP4-antibody

negtive
serum AQP4-antibody is negtive
Diagnostic Test: serum AQP4-antibody testing method
there are different methods of testing serum AQP4-antibody




Primary Outcome Measures :
  1. misdiagnosis rate [ Time Frame: 3 years ]
    misdiagnosis rate of NMOSD



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who are clinically suspected of being NMOSD
Criteria

Inclusion Criteria:

  1. more than 14 years old
  2. Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015

Exclusion Criteria:

  1. less than 14 years old
  2. NOT Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514030


Locations
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China, Beijing
Beijing Tongren Hospital,Capital Medical University
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Beijing Tongren Hospital

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Responsible Party: Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT03514030     History of Changes
Other Study ID Numbers: 2018-2
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuromyelitis Optica
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs