The French Cohort and Biobank of Devic's Neuromyelitis Op... | NCT02850705

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

NCT02850705

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Mar 31, 2022Actual

Enrollment

1,787Actual

Phase

Not provided

Conditions

Neuromyelitis Optica Spectrum Disorders
Neuromyelitis Optica Spectrum Related Disorders

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010Actual

Primary Completion Date

Nov 2021Actual

Completion Date

Nov 2021Actual

First Submitted Date

Jul 22, 2016

First Submission Date that Met QC Criteria

Jul 27, 2016

First Posted Date

Aug 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2022

Last Update Posted Date

Mar 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,787Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of cases of NMO or NMOSD included in the cohort		At 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with Devic's Neuromyelitis Optica NMO

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer		Bron		69500	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38185760	Derived	Januel E, Brochard V, Le Guennec L, Maillart E, Louapre C, Lubetzki C, Weiss N, Demeret S, Papeix C. Risk factors and prognosis of orotracheal intubation in aquaporin-4-IgG neuromyelitis optica spectrum disorder attacks. Ann Intensive Care. 2024 Jan 8;14(1):4. doi: 10.1186/s13613-023-01213-x.
37290967	Derived

ID	Term
D009471	Neuromyelitis Optica
D009187	Myelitis
D009902	Optic Neuritis
D003711	Demyelinating Diseases

ID	Term
D009188	Myelitis, Transverse
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases