Blood test could predict brain inflammation relapses in kids
NCT ID NCT06863974
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to find blood-based biomarkers that can predict whether a child with acute disseminated encephalomyelitis (ADEM) will experience relapses. Researchers will analyze immune cells from blood samples of 20 children aged 1-18 with a first demyelinating event. The goal is to identify molecular or cellular signatures that indicate a higher risk of recurrence, enabling earlier use of disease-modifying therapies to prevent long-term disability.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors predict which children with ADEM will have relapses, allowing earlier treatment to prevent long-term damage.
- What could go wrong
- This is a small, early observational study with only 20 participants, so findings may not apply to all patients. It looks for patterns in blood, not a treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Montpellier
NOT_YET_RECRUITINGMontpellier, 34295, France
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CHU d'Angers
RECRUITINGAngers, 49240, France
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Hôpital Necker Enfants Malades
NOT_YET_RECRUITINGParis, 75015, France
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Univesity Hostipal of APHP
RECRUITINGLe Kremlin-Bicêtre, 94270, France
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Univesity Hostipal of Brest
RECRUITINGBrest, 29200, France
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Univesity Hostipal of Nantes
RECRUITINGNantes, 44093, France
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Univesity Hostipal of Rennes
RECRUITINGRennes, 35000, France
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Univesity Hostipal of Tours
RECRUITINGTours, 37000, France
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- Can starting treatment right after a first attack prevent relapses in children?
- New MRI techniques could sharpen diagnosis of optic nerve inflammation
- Can a simple blood test unlock the secrets of brain autoimmune diseases?
- Genetic clues may forecast multiple sclerosis after vision loss