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

Launched by UNIVERSITY HOSPITAL, ANGERS · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding a condition called Acute Disseminated Encephalomyelitis (ADEM), which is an inflammatory disorder affecting the brain and spinal cord, especially in children. The researchers aim to find specific markers, or "biomarkers," in the blood that can help predict if a child with ADEM will experience a relapse or return of symptoms. By studying the genetic information from immune cells in the blood, they hope to identify these biomarkers early in the disease process, allowing for timely treatment to prevent further problems.

To be eligible for the study, children between the ages of 1 and 18 who have experienced their first episode of a demyelinating event, such as ADEM, optic neuritis, or myelitis, can participate. Participants must have confirmed anti-MOG antibodies in their blood if they are in the MOGAD/ADEM group. The trial is not yet recruiting, but once it starts, participants will undergo tests to help researchers learn more about their condition and may receive treatments aimed at reducing the risk of future episodes. Parents will need to provide consent for their child to join the study, and all participants will be monitored closely throughout the process.

Gender

ALL

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