NCT04376411

Brief 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 Behcet Disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 3, 2020

Last Update Submit

May 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day (done once)

Study Arms (2)

patients with Behcet disease

Flow-cytometric assay Detailed 2 Di mention Echocardiographic analysis Two-Dimensional speckle tracking echocardiography

Diagnostic Test: Flow-cytometric assayDiagnostic Test: 2D Echocardiographic analysisDiagnostic Test: Two-Dimensional speckle tracking echocardiography

Healthy control subjects

Flow-cytometric assay

Diagnostic Test: Flow-cytometric assay

Interventions

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.

Healthy control subjectspatients with Behcet disease

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

patients with Behcet disease

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.

patients with Behcet disease

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Thirty five adult patients who fulfilled the diagnostic criteria of Behcet Disease, and 39 age and sex matched healthy subjects as control

You may qualify if:

  • Thirty five adult patients who fulfilled the diagnostic criteria of Behcet Disease, and 39 age and sex matched healthy subjects as control

You may not qualify if:

  • Patients younger than 18 years old and those who were affected by other rheumatic disease other than Behcet Disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

May 3, 2020

First Posted

May 6, 2020

Study Start

December 15, 2018

Primary Completion

March 30, 2019

Study Completion

December 15, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations