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Completed

NCT Number: NCT04376411

Role of Regulatory B Cells in Behçet's Disease

There are limited data about the role of regulatory B cells in Behcet Disease. In this study we aimed to identify the proportions of total B lymphocytes and their regulatory subset in different Behcet Disease phenotype and therapies concentrating on the cardiovascular system attempting to unravel their function in Behcet Disease.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flow-cytometric assay

Diagnostic Test

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.

2D Echocardiographic analysis

Diagnostic Test

Trans thoracic echocardiographic examination was performed through (PHILIPS -33) echocardiography device with broadband S5-1 transducer

Two-Dimensional speckle tracking echocardiography

Diagnostic Test

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.

Primary outcomes

  1. percentage of B and B regulatory cells in different Behcet phenotype

    Time frame: 1 day (done once)

    correlation between the B and B regulatory cells with different presentations of Behcet disease especially the cardiovascular manifestations.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Possible Role of Regulatory B Cells in Behçet's Disease: Special Interest in Cardiovascular System

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 6, 2020
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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