Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02850705
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2016-07-22
Brief Title:
The French Cohort and Biobank of Devics Neuromyelitis Optica and Related Neurological Disorders NMOSD NOMADMUS
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
The French Cohort and Biobank of Devics Neuromyelitis Optica and Related Neurological Disorders NMOSD NOMADMUS
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOMADMUS
Brief Summary:
Devics 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None