Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06863974

High-throughput Omic Technology for Identification of Biomarkers of Relapsing Acute Disseminated Encephalomyelitis in Immune Cell Network

Led by University Hospital, Angers · Updated on 2026-04-27

20

Participants Needed

8

Research Sites

219 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute disseminated encephalomyelitis (ADEM) is a neuroinflammatory disorder of the central nervous system, manifesting itself as impaired consciousness, even to the point of coma, and multifocal neurological deficits. ADEM is the most common encephalitis in children. Moreover, 50-65% of ADEM in children is associated with the presence of anti-MOG antibodies (MOGAD). In fact, ADEM is the most frequent clinical presentation of MOGAD in children, 50-75% before the age of 10. The risk of recurrence is higher in pediatric MOGAD of ADEM manifestation, up to 30%, compared to myelitis or optic neuritis. Multiphasic MOGAD are more frequently associated with sequelae in 50-69% of cases, versus 4-32% for monophasic forms. In ADEM, cognitive and epileptic sequelae predominate. The 2020 European consortium and the 2022 national diagnosis and care protocol recommend the introduction of disease-modifying therapies as early as the second attack of the disease, or in the event of distant sequelae, in order to limit relapses and sequelae. However, these treatments take several months to take effect. There is currently no reliable predictive factor for MOGAD recurrence other than the persistence of an elevated blood anti-MOG antibody level (≥1:1280) at 1 year. The aim of this study is therefore to identify biomarkers associated with MOGAD recurrence from the first attack. To this end, we will study the transcriptome of circulating blood mononuclear cells by single-cell next-generation RNA sequencing in children with anti-MOGAD neuroinflammatory relapses. Anticipating the multiphasic trajectory of the disease would enable the introduction of early disease-modifying therapy to prevent recurrences and long-term sequelae. Furthermore, the discovery of a molecular and/or cellular signature would provide a better understanding of the pathophysiology of ADEM and MOGAD.

CONDITIONS

Official Title

High-throughput Omic Technology for Identification of Biomarkers of Relapsing Acute Disseminated Encephalomyelitis in Immune Cell Network

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 1 and 18 years (inclusive)
  • First demyelinating event such as ADEM encephalitis, optic neuritis (NORB), myelitis, or combination of these
  • Informed consent signed by the patient's legal representative
  • Patient affiliated to or benefiting from a social security scheme
  • For MOGAD/ADEM group: presence of serum anti-MOG antibodies and diagnosis of ADEM at first demyelinating attack
  • For Non-MOGAD/ADEM group: negative anti-MOG antibodies and diagnosis of ADEM at first demyelinating attack
  • For MOGAD/non-ADEM group: presence of serum anti-MOG antibodies and diagnosis of myelitis and/or NORB at first demyelinating attack
  • For retrospective recruitment: PBMC collected at first demyelinating event before immunomodulatory treatment, cryopreserved and available
  • For retrospective recruitment: samples at 6 and 24 months after first demyelinating event available if inclusion is beyond 6 to 24 months
Not Eligible

You will not qualify if you...

  • Immunosuppressive therapy within 6 months prior to treatment for first demyelinating event
  • Systemic corticosteroid therapy or immunomodulating doses of IV immunoglobulin or plasma exchange within 3 months prior to treatment for first demyelinating event
  • Brain MRI not performed at diagnosis of first demyelinating event
  • Poor understanding of the French language

AI-Screening

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Trial Site Locations

Total: 8 locations

1

CHU d'Angers

Angers, France, 49240

Actively Recruiting

2

Univesity Hostipal of Brest

Brest, France, 29200

Actively Recruiting

3

Univesity Hostipal of APHP

Le Kremlin-Bicêtre, France, 94270

Actively Recruiting

4

CHU Montpellier

Montpellier, France, 34295

Not Yet Recruiting

5

Univesity Hostipal of Nantes

Nantes, France, 44093

Actively Recruiting

6

Hôpital Necker Enfants Malades

Paris, France, 75015

Not Yet Recruiting

7

Univesity Hostipal of Rennes

Rennes, France, 35000

Actively Recruiting

8

Univesity Hostipal of Tours

Tours, France, 37000

Actively Recruiting

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Research Team

N

Nail BENALLEGUE, DOCTOR

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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