Expression of CXCR4 in Patients With Systemic Lupus Erythematosus

NCT04799730 | Unknown

• 1 other identifier: Soh-Med-21-03-01
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to estimate the possible role of CD184 in the pathogenesis of SLE; comparing its level among SLE cases to healthy controls.

Conditions

Systemic Lupus Erythematosus

Keywords

CXCR4,CD184,Flow cytometry ,Systemic lupus erythematosus

Outcome Measures

Primary Outcomes (1)

• changes in the expression of CD184(CXCR4) expression in circulating B cells

  Flow cytometry analysis of chemokine receptor (CXCR4):Human peripheral-blood mononuclear cells (PBMCs) labeling with CXCR4 antibody will be performed in the same day after taking blood samples and subsequent measurement of the CXCR4 mean fluorescence intensity (MFI) by flow cytometry. MFI of the anti-chemokine receptor (CXCR4) staining will be calculated according to statistical thresholds set in reference to staining with negative control antibodies. The patient's CXCR4 on CD19+ B cells expression or mean MFI will be further compared to the MFI of the simultaneously performed age-matched controls samples and other subgroups of SLE patients.

  6 months

Study Arms (3)

SLE cases in remission

according to SLE Disease Activity Index (SLEDAI) inactive disease will be considered as SLEDAI \<5

SLE cases in activity

according to SLE Disease Activity Index (SLEDAI) Active disease will be defined as SLEDAI ≥ 5

Control group

Healthy age and sex matched subjects.

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Study population will be classified into two group: 1. SLE patients group: Confirmed SLE patients diagnosed and fulfilled the SLE classification criteria according to the 2019 ACR/EULAR classification criteria for SLE (Aringer et al., 2019). 2. Control group: Healthy age and sex matched subjects. Then SLE group I patients will be subdivided according to the disease activity to three subgroups: I. Group A: SLE cases in remission II. Group B: SLE cases in activity, but no internal organ involvement (i.e. only mucocutaneus and/or musculoskeletal involvement). III. Group C: SLE cases in activity, and with internal organ involvement (renal, neuropsychiatric, hematological or cardiopulmonary).

You may qualify if:

• Confirmed SLE patients diagnosed and fulfilled the SLE classification criteria according to the 2019 ACR/EULAR classification criteria for SLE (Aringer et al., 2019)
• Willing and agreed to be included in the study.

You may not qualify if:

• Childhood SLE.
• SLE-patients will refuse to consent to this study.
• Other autoimmune diseases.
• Known or suspected malignancies, especially B cell lymphoma.

Sponsors & Collaborators

• Sohag University: lead

Biospecimen

Retention: SAMPLES WITH DNA

patient's peripheral-blood mononuclear cells (PBMCs) will be isolated from heparinized venous blood

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Asmaa A Ibrahim, Master

CONTACT

01032138809; smaibrahim2019@gmail.com

Shereen Philip Aziz, Professor

CONTACT

01033386104

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the Master Degree in Clinical and Chemical Pathology

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 16, 2021
• Study Start: May 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: May 1, 2022
• Last Updated: March 16, 2021

Record last verified: 2021-03