Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / NCT07375940
Recruiting Not applicable

Clinical, Biochemical and Epigenetic Profile of Pediatric Behçet Disease

NCT07375940 · tracked via the Priya Life Science Italy tracker
Sponsor
Meyer Children's Hospital IRCCS
Phase
Not applicable
Started
2026-01-12
Last updated
2026-01-29

Condition(s) studied

Behcet Disease and Vascular Involvement

Investigational drug(s) / intervention(s)

Biomarker analysis of blood samplesBiomarker analysis of blood samplesBiomarker analysis of blood samples

Biomarker analysis of blood samples: Research laboratory analyses will be performed on blood samples collected during routine clinical care. For pediatric Behçet disease patients, analyses include cytokine profiling (IL-6, IL-10, IL-17, TNF-α), circulating microRNA profiling, DNA methylation profiling, and targeted genetic sequencing for genes associated with monogenic Behçet-like phenotypes.

Biomarker analysis of blood samples: Research laboratory analyses will be performed on blood samples collected during routine clinical care. For Adult Behçet disease patients, analyses include cytokine profiling (IL-6, IL-10, IL-17, TNF-α), circulating microRNA profiling, DNA methylation profiling, and targeted genetic sequencing for genes associated with monogenic Behçet-like phenotypes.

Biomarker analysis of blood samples: Research laboratory analyses will be performed on blood samples collected during routine clinical care. For healthy pediatric controls, analyses are limited to circulating microRNA profiling and DNA methylation profiling only; no genetic testing/DNA sequencing will be performed in this group.

Study summary

Behçet disease (BD) is a chronic multisystem inflammatory disorder with a relapsing-remitting course. Pediatric-onset BD is rare and characterized by marked clinical heterogeneity, frequent incomplete presentation at disease onset, and limited availability of pediatric-specific outcome measures and biomarkers.

This prospective multicenter study aims to comprehensively characterize the clinical, biochemical, genetic, and epigenetic profiles of pediatric patients with Behçet disease and to compare them with adult BD patients and healthy pediatric controls.

The study focuses on the identification of disease-associated cytokine patterns, circulating microRNA profiles, DNA methylation signatures, and genetic variants associated with monogenic autoinflammatory diseases presenting with a Behçet-like phenotype.

By integrating clinical data with multi-omic analyses, this study seeks to identify biologically and clinically meaningful patient subgroups, improve disease stratification, and explore potential biomarkers of disease activity and remission in pediatric Behçet disease.

Eligibility

Sex
ALL
Min age
6 Months
Max age
70 Years
Healthy volunteers
No
Cases Inclusion Criteria : * BD diagnosis according to at least one of the three sets of classification criteria \[International Criteria for Behçet's Disease (ICBD), International Study Group (ISG) and Pediatric Behçet's disease criteria PEDBD)\]; * Age 6 months to 70 years old. * Written informed consent from appropriate legal representative(s), and assent from patients who have not reached the age of consent. Cases Exclusion Criteria: * Patients who do not meet the BD criteria OR * Patients for whom an alternative diagnosis was not investigated and/or excluded OR * Absence of a written informed consent. Healthy pediatric controls: * Patients evaluated at the Meyer Children's Hospital IRCCS Rheumatology Outpatient Clinic who are scheduled to undergo routine hematochemical tests, not for suspected inflammatory or autoimmune conditions. * Age \< 18 years, matched 1:1 by age and sex with the pediatric Behçet disease (BD) cohort. * Absence of recent or ongoing inflammatory conditions, verified through structured medical history and physical examination. * No clinical signs suggestive of chronic autoinflammatory or autoimmune diseases at physical examination . * No recent prolonged use (more than 7 consecutive days within the past 4 weeks) of anti-inflammatory, glucocorticoids, immunomodulatory, therapies or antibiotics. * Written informed consent from the legal guardian(s) and assent from minors when appropriate. Healthy Controls Exclusion Criteria * Diagnosis of acute or chronic inflammatory, autoimmune, or autoinflammatory conditions after the collection of structured medical history and physical examination * Current or recent prolonged use (more than 7 consecutive days within the past 4 weeks) of anti-inflammatory drugs, gluccocorticoids, immunomodulatory agents, or antibiotics. * Routine blood tests not performed during the visit. * Absence of written informed consent.

Primary outcome measure(s)

  • Quantitative biomarker profiles in Behçet disease — Up to 24 months
    Quantitative measurement of circulating biomarker levels in blood samples, including serum cytokine concentrations (IL-6, IL-10, IL-17, TNF-α), circulating microRNA expression levels, DNA methylation beta values at genome-wide CpG sites, and presence or absence of pathogenic genetic variants associated with monogenic Behçet-like diseases. Biomarker measurements will be obtained in pediatric and adult patients with Behçet disease and, where applicable, compared with healthy pediatric controls to evaluate differences across disease status and age groups.

Trial sites (2)

FacilityCityRegionStatus
Aou Meyer IRCSS Florence Florence Recruiting
Alder Hey Children's Hospital, Liverpool Liverpool Not Yet Recruiting

More Meyer Children's Hospital IRCCS trials in Italy

Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population Recruiting
Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age Recruiting
Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis Recruiting
SLIT ABS: Study on Patients With Autoimmune Podocytopathy Recruiting
Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07375940 on ClinicalTrials.gov ↗ ← All trials in Italy