- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04799730
Expression of CXCR4 in Patients With Systemic Lupus Erythematosus
Study of CD184 in Systemic Lupus Erythematosus
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Asmaa A Ibrahim, Master
- Phone Number: 01032138809
- Email: smaibrahim2019@gmail.com
Study Contact Backup
- Name: Shereen Philip Aziz, Professor
- Phone Number: 01033386104
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Study population will be classified into two group:
- 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).
- 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).
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in the expression of CD184(CXCR4) expression in circulating B cells
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-03-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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