Behcet DiseaseNCT04376411
Role of Regulatory B Cells in Behçet's Disease
An observational study of Behcet Disease, run by Assiut University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Behcet Disease
- What is being tested?
- Flow-cytometric assay, 2D Echocardiographic analysis and Two-Dimensional speckle tracking echocardiography
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2018to 15 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Thirty five adult patients who fulfilled the diagnostic criteria of Behcet Disease, and 39 age and sex matched healthy subjects as control
Who may be able to join
- Thirty five adult patients who fulfilled the diagnostic criteria of Behcet Disease, and 39 age and sex matched healthy subjects as control
Who cannot join
- Patients younger than 18 years old and those who were affected by other rheumatic disease other than Behcet Disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Possible Role of Regulatory B Cells in Behçet's Disease: Special Interest in Cardiovascular System
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.
Read the 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.
- Conditions
- Behcet Disease
- Being tested
- Flow-cytometric assay, 2D Echocardiographic analysis, Two-Dimensional speckle tracking echocardiography
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow-cytometric assayDiagnostic 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 analysisDiagnostic test
Trans thoracic echocardiographic examination was performed through (PHILIPS -33) echocardiography device with broadband S5-1 transducer
Two-Dimensional speckle tracking echocardiographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| patients with Behcet disease | Flow-cytometric assay Detailed 2 Di mention Echocardiographic analysis Two-Dimensional speckle tracking echocardiography Receives: Diagnostic Test: Flow-cytometric assay; Diagnostic Test: 2D Echocardiographic analysis; Diagnostic Test: Two-Dimensional speckle tracking echocardiography | |
| Healthy control subjects | Flow-cytometric assay Receives: Diagnostic Test: Flow-cytometric assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of B and B regulatory cells in different Behcet phenotype
correlation between the B and B regulatory cells with different presentations of Behcet disease especially the cardiovascular manifestations.
Measured: 1 day (done once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start15 Dec 2018
- Primary completion30 Mar 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behcet DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, safaa Mahran, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376411
- Sponsor's protocol ID
- 17300388
- Status last verified
- May 2020
- First submitted
- 3 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Role of Regulatory B Cells in Behçet's Disease: Special Interest in Cardiovascular System
- ClinicalTrials.gov ID
- NCT04376411
- Acronym / sponsor ID
- 17300388
- Conditions
- Behcet Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with Behcet disease | – | Diagnostic Test: Flow-cytometric assay, Diagnostic Test: 2D Echocardiographic analysis, Diagnostic Test: Two-Dimensional speckle tracking echocardiographyFlow-cytometric assay Detailed 2 Di mention Echocardiographic analysis Two-Dimensional speckle tracking echocardiography |
| Healthy control subjects | – | Diagnostic Test: Flow-cytometric assayFlow-cytometric assay |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Thirty five adult patients who fulfilled the diagnostic criteria of Behcet Disease, and 39 age and sex matched healthy subjects as control
Key inclusion criteria (1 listed)
- Thirty five adult patients who fulfilled the diagnostic criteria of Behcet Disease, and 39 age and sex matched healthy subjects as control
Key exclusion criteria (1 listed)
- Patients younger than 18 years old and those who were affected by other rheumatic disease other than Behcet Disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow-cytometric assay100 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. | Diagnostic test | Healthy control subjects, patients with Behcet disease |
| 2D Echocardiographic analysisTrans thoracic echocardiographic examination was performed through (PHILIPS -33) echocardiography device with broadband S5-1 transducer | Diagnostic test | patients with Behcet disease |
| Two-Dimensional speckle tracking echocardiographyTwo-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. | Diagnostic test | patients with Behcet disease |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Background1- 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behcet Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of B and B regulatory cells in different Behcet phenotype (time frame: 1 day (done once)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.