Systemic Lupus ErythematosusNCT04799730
Expression of CXCR4 in Patients With Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by Sohag University.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2021to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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.
Who cannot join
- Childhood SLE.
- SLE-patients will refuse to consent to this study.
- Other autoimmune diseases.
- Known or suspected malignancies, especially B cell lymphoma.
Trial locations and contacts
No sites are listed yet.
Shereen Philip Aziz, Professor contact
About this study
Official title: Study of CD184 in Systemic Lupus Erythematosus
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.
Read the detailed 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
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- CXCR4,CD184,Flow cytometry ,Systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdelfattah Ibrahim, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799730
- Sponsor's protocol ID
- Soh-Med-21-03-01
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of CD184 in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04799730
- Acronym / sponsor ID
- Soh-Med-21-03-01
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- CXCR4,CD184,Flow cytometry ,Systemic lupus erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Childhood SLE.
- SLE-patients will refuse to consent to this study.
- Other autoimmune diseases.
- Known or suspected malignancies, especially B cell lymphoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shereen Philip Aziz, Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa A Ibrahim, Master (01032138809, smaibrahim2019@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the expression of CD184(CXCR4) expression in circulating B cells (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.