NCT07375940 Clinical, Biochemical and Epigenetic Profile of Pediatric Behçet Disease
| NCT ID | NCT07375940 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meyer Children's Hospital IRCCS |
| Condition | Behcet Disease and Vascular Involvement |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2036-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-01-12 with a primary completion date of 2036-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07375940 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 70 Years, studying Behcet Disease and Vascular Involvement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07375940 currently recruiting?
Yes, NCT07375940 is actively recruiting participants. Contact the research team at gabriele.simonini@unifi.it for enrollment information.
Where is the NCT07375940 trial being conducted?
This trial is being conducted at Florence, Italy, Liverpool, United Kingdom.
Who is sponsoring the NCT07375940 clinical trial?
NCT07375940 is sponsored by Meyer Children's Hospital IRCCS. The trial plans to enroll 90 participants.