Serum Elafin and Vascular Affection in Behcet Disease
February 16, 2024 updated by: Lobna Amer Araby Ahmed, Assiut University
Serum Elafin: A Biomarker in Behcet Disease and Its Relation to Vascular Involvement and Disease Activity
To measure the level of serum elafin in patients with BD. To assess the relation between serum elafin levels and disease activity. To evaluate the vascular complications in BD and determine their relationship with disease activity.
To assess the correlation between serum elafin and vascular affection and their relation with disease activity.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Behçet's disease (BD) is a chronic, multisystemic, inflammatory disease characterized by recurrent oral and genital ulcers and multiple systemic involvements.
Elafin is a serine protease inhibitor produced mainly by epithelial cells.
Its expression is upregulated by proinflammatory cytokines such as IL-1β and TNF-α that are potent stimulants of neutrophil activation, it counteracts the destructive effects of neutrophil elastase .Interestingly, previous reports documented the role of serum elafin in the pathogenesis of BD.In fact, vascular complications may be one of the earliest manifestations leading to the diagnosis of BD.
There is no reliable tool to identify vascular wall inflammation in BD, except for detecting intravascular thrombosis with ultrasonography (US).
Previous studies investigated arterial vessel wall thickness with US (mostly in carotid arteries) in BD .
Venous wall inflammation presents with deep vein thrombosis and superficial thrombophlebitis .
It was stated that lower extremity vein wall thickness (VWTs)was increased in BD patients independently of vascular activity and important in the diagnosis .
However, studies in the literature evaluated only lower extremity VWTs, whereas the relationship of VWT with disease activity has not been emphasized .
Study Type
Observational
Enrollment (Estimated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lobna Amer, MD
- Phone Number: 01019313530
- Email: lobnaamer20@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed as BD.
Age of all participants (20-45) years.
Description
Inclusion Criteria:
Patients diagnosed as BD. Age of all participants (20-45) years.
Exclusion Criteria:
Age <20 or >45 years. Other autoimmune diseases. Cardiovascular diseases (heart failure, myocardial ischemia). Possible related risk factors (e.g. diabetes, dyslipidemia, smoking). chronic conditions (e.g. chronic kidney disease, malignancy, autoimmune diseases).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
45 patients with behcet disease
|
doppler US
|
|
45 healthy participants
|
doppler US
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring the level of serum Elafin in patients with BD in comparison to healthy participants.
Time Frame: within one year
|
Measuring the level of serum Elafin in patients with BD in comparison to healthy participants.
|
within one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Calamia KT, Schirmer M, Melikoglu M. Major vessel involvement in Behcet's disease: an update. Curr Opin Rheumatol. 2011 Jan;23(1):24-31. doi: 10.1097/BOR.0b013e3283410088.
- Kutlay A, Kose AA. Serum Elafin as a Potential Marker of Disease Activity in Behcet's Disease. Indian J Dermatol. 2023 Jul-Aug;68(4):372-376. doi: 10.4103/ijd.ijd_913_22.
- Yazici Y, Hatemi G, Bodaghi B, Cheon JH, Suzuki N, Ambrose N, Yazici H. Behcet syndrome. Nat Rev Dis Primers. 2021 Sep 16;7(1):67. doi: 10.1038/s41572-021-00301-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
February 16, 2024
First Submitted That Met QC Criteria
February 16, 2024
First Posted (Estimated)
February 22, 2024
Study Record Updates
Last Update Posted (Estimated)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 16, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- behcet and vascular
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.