Clinical, Biochemical and Epigenetic Profile of Pediatric Behçet Disease (NCT07375940) | Clinical Trial Compass
RecruitingNot Applicable
Clinical, Biochemical and Epigenetic Profile of Pediatric Behçet Disease
Italy, United Kingdom90 participantsStarted 2026-01-12
Plain-language 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.
Who can participate
Age range
6 Months – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused on Behçet disease with vascular involvement specifically, can you help me understand whether my child's type and severity of Behçet disease matches what this trial is looking at?
2This trial seems to be collecting clinical, biochemical, and epigenetic information rather than testing a new treatment — does that mean my child would not receive any experimental therapy as part of participating, and would their current treatment plan stay the same?
3Because this is listed as 'Phase NA,' it appears to be an observational or registry-style study rather than a drug trial — can you explain what that means for my child's safety and what exactly would be asked of us, such as blood draws, clinic visits, or other procedures?
4The study is measuring biomarker profiles, which could help researchers better understand Behçet disease in children — but is there any direct benefit my child might see from participating, or is the benefit mainly for future patients and research?
5Given that this trial is actively recruiting right now, are there other study sites or alternative research studies on pediatric Behçet disease we should also be aware of, so we can compare our options before deciding?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.