Advanced omics to find biomarkers for relapsing pediatric ADEM

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

This project will test whether high-throughput omics on blood samples can find biomarkers that predict relapse in children and teens with ADEM or MOG-antibody-associated demyelination.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Angers (other gov)
• Locations: 8 sites (Angers and 7 other locations)
• Trial ID: NCT06863974 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children and adolescents aged 1–18 at their first demyelinating event (ADEM, optic neuritis, or myelitis), with informed consent from a legal representative and social security coverage, are ideal candidates.

Not a fit: Adults, patients with non-demyelinating causes of encephalitis, or those already well past their first attack are unlikely to benefit directly from the study's biomarker findings.

Why it matters

Potential benefit: If successful, clinicians could identify children at higher risk of relapse and offer earlier disease-modifying therapy to reduce long-term cognitive and epileptic sequelae.

How similar studies have performed: Anti-MOG antibody research has established clinical associations with ADEM, but applying high-throughput multi-omic profiling to predict relapse is largely exploratory with limited prior success.

Eligibility criteria

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 this trial is running

Angers and 7 other locations

• CHU d'Angers — Angers, France (RECRUITING)
• Univesity Hostipal of Brest — Brest, France (RECRUITING)
• Univesity Hostipal of APHP — Le Kremlin-Bicêtre, France (RECRUITING)
• CHU Montpellier — Montpellier, France (NOT_YET_RECRUITING)
• Univesity Hostipal of Nantes — Nantes, France (RECRUITING)
• Hôpital Necker Enfants Malades — Paris, France (NOT_YET_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

Conditions: Acute Disseminated Encephalomyelitis, Encephalitis Autoimmune