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RECRUITING
NCT07375940
NA

Clinical, Biochemical and Epigenetic Profile of Pediatric Behçet Disease

Sponsor: Meyer Children's Hospital IRCCS

View on ClinicalTrials.gov

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.

Official title: Clinical, Biochemical and Epigenetic Profile of Pediatric Behçet Disease: Similarities and Differences From Adult Patients and Looking for Potential Biomarkers.

Key Details

Gender

All

Age Range

6 Months - 70 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-01-12

Completion Date

2036-01

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Locations (2)

Aou Meyer IRCSS

Florence, Florence, Italy

Alder Hey Children's Hospital,

Liverpool, Liverpool, United Kingdom