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The French Cohort and Biobank of Devic's Neuromyelitis Optica and Related Neurological Disorders (NMOSD) (NOMADMUS) (NOMADMUS)

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ClinicalTrials.gov Identifier: NCT02850705
Recruitment Status : Recruiting
First Posted : August 1, 2016
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Devic's neuromyelitis optica (NMO) is rare. Epidemiological and demographic data are poor, based mainly on monocentric cohorts. Moreover, NMO might be difficult to distinguish from multiple sclerosis and begin with atypical or incomplete clinical presentations. Therefore, NMO is still underdiagnosed. The constitution of a nationwide and prospective cohort, including not only NMO but also clinical syndromes suggestive of a first episode (DNMO-spectrum disorders (SDs)), should allow to gather a critical mass of cases and answer questions that could not have been addressed at the level of a single centre.

Objectives: The main objective is to describe the clinical, radiological and biological features of NMO spectrum disorder (NMO, isolated longitudinally extensive transverse myelitis (LETM), relapsing or not; isolated atypical optic neuritis (ON)) and their evolution. The second aim is to create a biobank dedicated to NMO (serum, whole blood for RNA and DNA extraction, cerebrospinal fluid), to promote translational research in the field. Methods: NOMADMUS is a prospective, multicentre, observational study of patients NMOSD and related disorder in France. Prevalent cases are included retrospectively and then followed prospectively. Incident cases are included from disease onset and followed prospectively. A minimal set of data has been defined and synthesized on specific paper forms derived from the European database for multiple sclerosis (EDMUS) forms. Patients are systematically tested regarding their AQP4-IgG and MOG-IgG status. All the data are centralised in a EDMUS-derived database in Lyon, the EDEN software. All cases are validated and classified by an expert committee.


Condition or disease
Neuromyelitis Optica Spectrum Disorders Neuromyelitis Optica Spectrum Related Disorders

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: The French Cohort and Biobank of Devic's Neuromyelitis Optica and Related Neurological Disorders (NMOSD) (NOMADMUS)
Study Start Date : January 2010
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020





Primary Outcome Measures :
  1. number of cases of NMO or NMOSD included in the cohort [ Time Frame: At 5 years ]

Biospecimen Retention:   Samples With DNA
Serum, CSF, DNA, PBMC


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Devic's Neuromyelitis Optica NMO
Criteria

Inclusion Criteria:

Definite Devic's Neuromyelitis Optica NMO according to established criteria (Wingerchuk 1999, Wingerchuk 2006, International panel 2015)

  • high risk syndromes for NMOSD, defined as: recurrent or simultaneous optic neuritis, idiopathic single or recurrent longitudinally extensive transverse myelitis (spinal cord lesion seen on MRI >3 vertebral segments)
  • patients tested positive for AQP4-IgG autoantibody or MOG-IgG autoantibody
  • living in France since 5 years minimum

Exclusion Criteria:

  • None

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): NCT02850705


Contacts
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Contact: Romain Marignier romain.marignier@chu-lyon.fr
Contact: Sandra Vukusic sandra.vukusic@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer Recruiting
Bron, France, 69500
Contact: Romain Marignier       romain.marignier@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

Additional Information:

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02850705     History of Changes
Other Study ID Numbers: D50742
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019

Keywords provided by Hospices Civils de Lyon:
Neuromyelitis Optica
Myelitis
Optic Neuritis
autoantibody
demyelination

Additional relevant MeSH terms:
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Disease
Neuromyelitis Optica
Nervous System Diseases
Pathologic Processes
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases