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Study identifier: NCT07718958 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: PANS · Pediatric Acute-Onset Neuropsychiatric Syndrome  ·  Sponsor: University of Cagliari

PhaseN/A
Planned participants80
Who can joinAll sexes, 3 Years to 18 Years
Healthy volunteersYes

About this study

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, and environmental factors such as stress or trauma. Current evidence suggests that both innate and adaptive immune responses contribute to disease pathophysiology through interactions between the peripheral immune system and the central nervous system. The pathogenic process may begin during fetal life through Maternal Immune Activation (MIA), whereby maternal infections or immune dysregulation induce inflammatory responses that increase susceptibility to neurodevelopmental disorders. During the postnatal period, infectious agents, including viruses, Mycoplasma pneumoniae, and Haemophilus i…

This description comes directly from the study's public registry record.

Talk to the study team

Monica MF Puligheddu, MD, PHD  ·  070 5109 6016  ·  puligheddu@unica.it

Antonella Gagliano, MD, PhD  ·  agagliano@oasi.en.it

Always discuss trial participation with your own doctor first.

Locations (5)

Centro di Medicina del Sonno, SC Neurologia, AOU CagliariCagliari, Cagliari, ItalyActive Not Recruiting
Università degli Studi eCampusNovedrate, CO, ItalyActive Not Recruiting
UOC NeuropsichiatriaTroina, Enna, ItalyActive Not Recruiting
Azienda Ospedaliera Universitaria Gaetano MartinoMessina, Messina, ItalyRecruiting
Dipartimento di Scienze Psicologiche, Pedagogiche, dell¿Esercizio Fisico e della FormazionePalermo, Palermo, ItalyActive Not Recruiting

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Source record: clinicaltrials.gov/study/NCT07718958