- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07845162
Serum EBI-3 Protein Levels in Behçet's Disease
Serum Epstein-Barr Virus-induced Gene 3 Protein Levels in Patients With Behçet's Disease
This cross-sectional study aims to evaluate serum Epstein-Barr virus-induced gene 3 (EBI-3) protein levels in patients with Behçet's disease compared with healthy controls.
Study Overview
Status
Conditions
Detailed Description
Behçet's disease is a chronic multisystem inflammatory disorder. Serum EBI-3 protein levels may reflect inflammatory activity.
This observational study will include adult patients diagnosed with Behçet's disease according to the International Criteria for Behçet's Disease and age-matched healthy controls. Serum EBI-3 protein levels will be measured by ELISA.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Shrouk S Mohamed, Resident
- Phone Number: 01004638754
- Email: shrouk.18313202@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Adult patients with Behçet's disease attending the Physical Medicine, Rheumatology and Rehabilitation Department at Assiut University Hospitals, and healthy controls.
Description
Inclusion Criteria:
- - Age 18 years or older
- Diagnosis of Behçet's disease according to the International Criteria for Behçet's Disease (cases)
- Healthy individuals without autoimmune or inflammatory diseases (controls)
- Written informed consent
Exclusion Criteria:
- - Other autoimmune disorders (RA, SLE, psoriatic arthritis, ankylosing spondylitis)
- Acute or chronic infection
- Malignancy or history of malignancy
- Chronic liver disease or advanced chronic kidney disease
- Pregnancy or lactation
- Vasculitis caused by diseases other than Behçet's disease
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_CONTROL
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
|---|
|
Behçet's Disease
Patients diagnosed with Behçet's disease according to the International Criteria for Behçet's Disease. |
|
Healthy Controls
Age-matched healthy individuals without autoimmune or inflammatory diseases. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean serum EBI-3 protein level
Time Frame: Baseline
|
Mean serum Epstein-Barr virus-induced gene 3 (EBI-3) protein concentration measured by ELISA in patients with Behçet's disease compared with healthy controls. |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum EBI-3 level according to disease activity
Time Frame: Baseline
|
Mean serum EBI-3 protein concentration according to Behçet's Disease Current Activity Form (BDCAF) score. |
Baseline
|
|
Serum EBI-3 level in patients with vascular involvement
Time Frame: Baseline
|
Mean serum EBI-3 protein concentration in patients with and without vascular involvement |
Baseline
|
|
Serum EBI-3 level in patients with ocular involvement
Time Frame: Baseline
|
Mean serum EBI-3 protein concentration in patients with and without ocular involvement. |
Baseline
|
|
Serum EBI-3 level in patients with neurological involvement
Time Frame: Baseline
|
Mean serum EBI-3 protein concentration in patients with and without neurological involvement. |
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gehan I Abdelraziq, prof, Physical Medicine, Rheumatology and Rehabilitation Department, Assiut University Hospitals
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mouth Diseases
- Stomatognathic Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Genetic Diseases, Inborn
- Eye Diseases
- Skin Diseases
- Skin Diseases, Vascular
- Skin Diseases, Genetic
- Uveal Diseases
- Vasculitis
- Panuveitis
- Uveitis, Anterior
- Uveitis
- Hereditary Autoinflammatory Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Skin and Connective Tissue Diseases
- Behcet Syndrome
Other Study ID Numbers
- EBI3-Behcet-Assiut-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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