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Biomarkers for Diagnosis and Treatment Response in Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)

Recruitingn/aAges 3 Years - 18 YearsAllUniversity of Cagliari
NCT07718958 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) is a complex neuropsychiatric disorder characterized by the abrupt onset of symptoms and currently diagnosed mainly on clinical criteria, as reliable diagnostic biomarkers are still lacking. The primary objective of this project is to identify and validate a panel of neurophysiological, molecular, genetic, and metabolomic biomarkers associated with disease onset, clinical trajectory, and response to antimicrobial, anti-inflammatory, and immunomodulatory treatments. Identifying objective biomarkers will improve diagnostic accuracy, facilitate earlier diagnosis, clarify disease mechanisms, and support the development of more targeted therapeutic strategies. PANS is currently considered a multifactorial immune-mediated inflammatory brain disorder resulting from the interaction of genetic susceptibility, immune dysregulation, infections

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📋 Eligibility rules (as published)
Inclusion Criteria: * (I) PANS diagnosis made according to 2010 NIH criteria Exclusion Criteria (for the PANS group): * (I) onset of specific rheumatologic or immunologic diseases; * (II) presence of a diagnosed cancer or other severe medical illnesses; * (III) active treatment with steroidal or non-steroidal anti-inflammatory drugs The control group must include children without autoimmune diseases, neurodevelopmental or psychiatric disorders, and with adequate academic performance and functional level.
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What it tests

  • Psycodiagnostic evaluation
  • Polysomnography
  • 1H-NMR analysis
  • miRNA sequencing
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Where

5 sites
Centro di Medicina del Sonno, SC Neurologia, AOU Cagliari
Cagliari, Italy
Università degli Studi eCampus
Novedrate, Italy
UOC Neuropsichiatria
Troina, Italy
Azienda Ospedaliera Universitaria Gaetano Martino
Messina, Italy
Dipartimento di Scienze Psicologiche, Pedagogiche, dell¿Esercizio Fisico e della Formazione
Palermo, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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