Advanced omics to find biomarkers for relapsing pediatric ADEM

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study collects blood samples from children aged 1–18 presenting with a first demyelinating event (ADEM, optic neuritis, or myelitis) and applies high-throughput multi-omic profiling to immune cells and serum. Participants are classified into groups by presence or absence of anti-MOG antibodies and by clinical presentation (MOGAD/ADEM, non-MOGAD/ADEM, and MOGAD/non-ADEM). Both prospective and retrospective cases will be included across three French pediatric neurology centers, with centralized laboratory analysis to identify molecular signatures in immune cell networks. The approach aims to correlate omic patterns with relapse risk and longer-term neurological outcomes.

Why it matters

Who can join: the full rules

Inclusion criteria:

Prospective recruitment Pre-inclusion criteria

* Age at inclusion between 1 and 18 years (included)
* First demyelinating event at inclusion, such as ADEM encephalitis, optic neuritis (NORB) or myelitis, or a combination of these conditions.
* Informed consent signed by patient's legal representative
* Patient affiliated to or benefiting from a social security scheme Inclusion criteria (confirmation of inclusion and follow-up in one of 3 groups)
* MOGAD/ADEM group: presence of serum anti-MOG antibodies and diagnosis of ADEM (according to the International Pediatric Multiple Sclerosis Society Group (IPMSSG) criteria revised in 2013) at the first demyelinating attack.
* Non-MOGAD/ADEM group: anti-MOG antibodies negative and diagnosis of ADEM at first demyelinating attack.
* MOGAD/non-ADEM group: presence of serum anti-MOG antibodies and diagnosis of myelitis and/or NORB at first demyelinating attack.

Retrospective recruitment General inclusion criteria

* Age at inclusion between 1 and 18 years (inclusive)
* Inclusion (signed consent of the patient's legal representative) in the biocollection from which the samples were taken at the latest at the time of management of a first demyelinating event of the ADEM encephalitis, optic neuritis (NORB) or myelitis type, or a combination of these disorders.
* PBMC collected at the time of the first demyelinating event before any immunomodulatory treatment, cryopreserved and available in the biocollection.
* Depending on the date of inclusion (if inclusion beyond 6 to 24 months after the first demyelinating event), samples taken at 6 months and then 24 months after the first demyelinating event available in the biocollection for the analyses planned in the study.
* Informed consent signed by patient's legal representative
* Patient affiliated to or benefiting from a social security scheme

Inclusion criteria specific to the 3 study groups

* MOGAD/ADEM group: presence of serum anti-MOG antibodies and diagnosis of ADEM (according to the International Pediatric Multiple Sclerosis Society Group (IPMSSG) criteria revised in 2013) at the first demyelinating attack.
* Non-MOGAD/ADEM group: anti-MOG antibodies negative and diagnosis of ADEM at first demyelinating attack.
* MOGAD/non-ADEM group: presence of serum anti-MOG antibodies and diagnosis of myelitis and/or NORB at first demyelinating attack.

Non-inclusion criteria (prospective or retrospective recruitment):

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

Where it's running

• CHU d'Angers
  Angers, France Recruiting
• Univesity Hostipal of Brest
  Brest, France Recruiting
• Univesity Hostipal of APHP
  Le Kremlin-Bicêtre, France Recruiting
• Univesity Hostipal of Nantes
  Nantes, France Recruiting
• Univesity Hostipal of Rennes
  Rennes, France Recruiting
• Univesity Hostipal of Tours
  Tours, France Recruiting

Study contacts

• Principal investigator: Nail BENALLEGUE, DOCTOR — University Hospital, Angers
• Study coordinator: Nail BENALLEGUE, DOCTOR
• Email: nail.benallegue@chu-angers.fr
• Phone: +33241354445

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.