Regulatory BCells in Systemic Lupus Erythematosus

NCT03178721 | Unknown

• 1 other identifier: breg
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many diagnostic and management challenges. One such challenge is the excess cardiovascular disease observed in patients with Systemic lupus erythematosus . Coronary heart disease and other manifestations of atherosclerosis continue to be a major cause of death in patients with Systemic lupus erythematosus.Regulatory B-cells have been identified as a negative regulator of the immune system that inhibit pathological immune response by suppressing both uncontrolled protective immune response and damaging autoimmune responses

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Coronary calcium scoring

  using Agatston score none (Agatston 0 U) mild (Agatston 1-99 U) moderate(Agatston 100-399 U) high(Agatston \>400 U)

  1year

Study Arms (2)

1

Systemic lupus erythematosus with atherosclerosis

Diagnostic Test: blood sample

2

Systemic lupus erythematosus without atherosclerosis

Diagnostic Test: blood sample

Interventions

blood sample DIAGNOSTIC_TEST

study B regulatory in blood and its correlation with atherosclerosis

Also known as: Coronary calcium scoring: all participants will be scanned using a 64-slice CT scanner and Carotid intimae media thickness (CIMT): Carotid artery ultrasonography

1; 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

adult patients with systemic lupus erythematosus

You may qualify if:

• Clinical and laboratory Diagnosis of Systemic Lupus disease.
• Must be adult.

You may not qualify if:

• Patients with clinical atherosclerotic vascular disease
• pregnancy.

Sponsors & Collaborators

• Assiut University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

1- 5ml fresh human peripheral whole blood was layered over a ficoll density gradient to isolate PBMCs. Breg cells will be sorted by fluorescently labelling PBMCs to identify Breg cells Quantification of the percentage of specific phenotype CD19+ CD38hi CD24hi of B-reg by using flow cytometry.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investegator

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 7, 2017
• Study Start: June 25, 2017
• Primary Completion: June 25, 2018
• Study Completion: July 25, 2018
• Last Updated: June 7, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share