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New treatment option for Behcet Disease and Vascular Involvement
Official title Clinical, Biochemical and Epigenetic Profile of Pediatric Behçet Disease
ClinicalTrials.gov ID: NCT07375940
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 70
You may be able to join if
- Cases
- BD diagnosis according to at least one of the three sets of classification criteria [International Criteria for Behçet's Disease (ICBD)...
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Cases
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Florence, Florence, Italy
- Liverpool, Liverpool, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florence, Florence, Italy; Liverpool, Liverpool, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.