- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04376411
Role of Regulatory B Cells in Behçet's Disease
Possible Role of Regulatory B Cells in Behçet's Disease: Special Interest in Cardiovascular System
Study Overview
Status
Conditions
Detailed Description
Behçet's disease is a chronic multi-organ vasculitis characterized by recurrent oral and genital aphthae, skin lesions, widespread thrombosis and aneurysmal formation, and serious involvement of the eyes and central nervous system.
The innate and adaptive immune cells integrate in the pathogenesis of Behçet's disease. Interestingly, the gene expression analysis of Behçet's disease patients and healthy controls revealed the modulation of a range of genes involved in biological processes in Behçet's disease such as inflammation, apoptosis, angiogenesis, blood coagulation, vascular damage, signalling pathways, and immune responses, particularly, in innate immune cells, Th17 cells and B cells. Yet, the regulatory role of B cells in Behçet's disease has not been thoroughly investigated. Therefore, the aim of the current study is to identify the proportions of total B lymphocytes and their regulatory subset in different Behçet's disease phenotypes and therapies attempting to unravel their function in Behcet Disease. The role of B cells and regulatory B cells in the cardiovascular system affection in Behcet Disease was studied in more details.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Assiut, Egypt, 71515
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Thirty five adult patients who fulfilled the diagnostic criteria of Behcet Disease, and 39 age and sex matched healthy subjects as control
Exclusion Criteria:
- Patients younger than 18 years old and those who were affected by other rheumatic disease other than Behcet Disease.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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patients with Behcet disease
Flow-cytometric assay Detailed 2 Di mention Echocardiographic analysis Two-Dimensional speckle tracking echocardiography
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100 µl of blood sample was incubated for 20 minutes at 4 C in the dark.
Following incubation, red blood cells lysis, washing and analysis a specific software.Forward and side scatter histogram was used to define the lymphocytes population.
Trans thoracic echocardiographic examination was performed through (PHILIPS -33) echocardiography device with broadband S5-1 transducer
Two-Dimensional speckle tracking echocardiography was performed on grey scale images of the left ventricle.
For offline analysis digital storage software (Qlab 10.4) was used.
The frame rate was adjusted to be 60-90 frame/second.
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Healthy control subjects
Flow-cytometric assay
|
100 µl of blood sample was incubated for 20 minutes at 4 C in the dark.
Following incubation, red blood cells lysis, washing and analysis a specific software.Forward and side scatter histogram was used to define the lymphocytes population.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of B and B regulatory cells in different Behcet phenotype
Time Frame: 1 day (done once)
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correlation between the B and B regulatory cells with different presentations of Behcet disease especially the cardiovascular manifestations.
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1 day (done once)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 1- Kural-Seyahi E, Fresko I, Seyahi N, Ozyazgan Y, Mat C, Hamuryudan V, et al. The long-term mortality and morbidity of Behcet syndrome: a 2-decade outcome survey of 387 patients followed at a dedicated center. Medicine (Baltimore). 2003;82(1):60-76. 2- Kirino Y, Bertsias G, Ishigatsubo Y, Mizuki N, Tugal-Tutkun I, Seyahi E, et al. Genome-wide association analysis identifies new susceptibility loci for Behcet's disease and epistasis between HLA-B*51 and ERAP1. Nat Genet. 2013;45(2):202-7. 3- Yoon JY, Lee Y, Yu SL, Yoon HK, Park HY, Joung CI, et al. Aberrant expression of interleukin-10 and activation-induced cytidine deaminase in B cells from patients with Behcet's disease. Biomed Rep. 2017;7(6):520-6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17300388
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
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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