- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06280430
Vascular Affection in Behcet Disease
February 20, 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 behcet disease and to assess the correlation between serum elafin and vascular affection and their relation with disease activity
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Behcet disease is a chronic multi systemic inflammatory disease characterized by recurrent oral and genital ulcers and multiple systemic affection .
Elafin is a serine protease inhibitor produced mainly by epithelial cells .
previous studies documented the role of serum elafin in pathogenesis of behcet disease.vascular
complications may be one if the earliest manifestation leading to the diagnosis of behcet disease.
Study Type
Observational
Enrollment (Estimated)
90
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
45 patients with behcet disease aged(20-45) in comparison with 45 heathy participant s
Description
Inclusion Criteria:
- patients diagnosed as behcet disease Age (20-45)
Exclusion Criteria:
- age <20 and >45 Other autoimmune diseases Risk factors (ischemic heart disease, diabetes) Chronic conditions (malignancy, chronic kidney disease)
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 |
---|
Healthy control group
|
Patients with behcet disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To measure the level of serum elafin in behcet patients and compare it with control group
Time Frame: Within 1year
|
Measure the level of serum elafin in behcet and its relation to disease activity and vascular involvement
|
Within 1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 20, 2024
First Submitted That Met QC Criteria
February 20, 2024
First Posted (Actual)
February 28, 2024
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vascular affection in behcet
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.
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