Expression of CXCR4 in Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

Study of CD184 in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04799730
• Other study ID #: Soh-Med-21-03-01
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: May 2022

Study information

• Verified date: March 2021
• Source: Sohag University
• Contact: Asmaa A Ibrahim, Master
• Phone: 01032138809
• Email: smaibrahim2019[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Detection of CXCR4 (CD184) expression on CD19+ B cells by flow cytometry in patients of SLE, comparing its level in the development of lupus activity and pathogenic process of SLE internal organ involvement/ mucocutaneus and/or musculoskeletal involvement. Identify this correlation will be useful for clarifying other accessory factors to improve the diagnosis, better treatment strategy, follow up as well as prognosis for these patients

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Childhood SLE.

• SLE-patients will refuse to consent to this study.

• Other autoimmune diseases.

• Known or suspected malignancies, especially B cell lymphoma.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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