Systemic LupusNCT03752983
Chemokine (CXCL13) as Anew Marker in Diagnosis of SLE
An observational study of Systemic Lupus, run by Assiut University.
Trial summary
Systemic lupus erythematosus (SLE) is systemic autoimmune disease characterized by various immunological abnormalities, including dysregulated activation of both T and B lymphocytes with overt production of autoreactive antibodies.The chemokine CXC ligand 13 protein (CXCL13), also known as B cell-attracting… Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus
- What is being tested?
- blood samples
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 1 Dec 2020
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: two groups: 46 patients with SLE 40 healthy people
Who may be able to join
- SLE patients diagnosed according to ACR
Who cannot join
- patient with other autoimmune diseases.
Trial locations and contacts
No sites are listed yet.
Wafaa El-Sherif, profeesor contact
About this study
Official title: Chemokine CXCL13 as a Marker of Disease Activity in Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is systemic autoimmune disease characterized by various immunological abnormalities, including dysregulated activation of both T and B lymphocytes with overt production of autoreactive antibodies.The chemokine CXC ligand 13 protein (CXCL13), also known as B cell-attracting chemokine-1 (BAC-1) or B lymphocyte chemoattractant (BLC), CXCL13 serum levels were correlated with disease activity using the SLE Disease Activity Index (SLEDAI) and to lupus nephritis
Read the detailed description
Systemic lupus erythematosus (SLE) is systemic autoimmune disease characterized by various immunological abnormalities, including dysregulated activation of both T and B lymphocytes with overt production of autoreactive antibodies . Lupus nephritis (LN) is the most common and serious complication in SLE patients characterized by proteinuria, hematuria, drop glomerular filtration rate, or renal dysfunction . It is known that B lymphocytes are involved in the pathogenesis of systemic lupus erythematosus in autoantibody-dependent mechanisms . The chemokine CXC ligand 13 protein (CXCL13), also known as B cell-attracting chemokine-1 (BAC-1) or B lymphocyte chemoattractant (BLC), is a CXC subtype member of the chemokine superfamily. The receptor of CXCL13 is CXCR5, which is normally expressed on mature B cells and follicular T helper cells (Tfh). It has been demonstrated that CXCL13 is sufficient to induce secondary lymphoid tissues in peripheral organs. It is well known that different chemokines are involved in the pathogenesis of LN by orchestrating proinflammatory microenvironments, recruiting immune cell subsets into the kidney and by inducing local activation of immune effector cells . Local B-cell infiltration and related abnormal expression of ectopic lymphoid tissue (ELT) in the renal tissues of LN mice models was related to the severity of renal impairment .
Of interest, in regions of B cell infiltration a higher expression level of CXCL13 was found. Most B cells in this region expressed the corresponding receptor CXCR5, also supporting the hypothesis that CXCL13 induces B cell infiltration into the kidneys via its receptor CXCR5 .
In one study on 91Caucasian patients, CXCL13 serum levels were correlated with disease activity using the SLE Disease Activity Index (SLEDAI) and to lupus nephritis. It was found that serum CXCL13 levels correlated well with SLEDAI and median CXCL13 concentrations were higher in patients with renal involvement .
- Conditions
- Systemic Lupus
- Being tested
- blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesDiagnostic test
blood samples
| Study group | Role | What they receive |
|---|---|---|
| cases | patients with SLE Receives: Diagnostic Test: blood samples | |
| controls | Healthy people Receives: Diagnostic Test: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
to measure the level of cxcl13 in SLE
to differentiate the level of (cxcl13) between healthy individuals and patients with SLE
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Mar 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic LupusStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Retrospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Khamis Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752983
- Sponsor's protocol ID
- CXCL13 in SLE
- Status last verified
- Nov 2018
- First submitted
- 22 Nov 2018
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmadpoor P, Dalili N, Rostami M. An update on pathogenesis of systemic lupus erythematosus. Iran J Kidney Dis. 2014 May;8(3):171-84.
PubMed 24878938
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemokine CXCL13 as a Marker of Disease Activity in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03752983
- Acronym / sponsor ID
- CXCL13 in SLE
- Conditions
- Systemic Lupus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 26 Nov 2018 (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.
Systemic lupus erythematosus (SLE) is systemic autoimmune disease characterized by various immunological abnormalities, including dysregulated activation of both T and B lymphocytes with overt production of autoreactive antibodies.The chemokine CXC ligand 13 protein (CXCL13), also known as B cell-attracting chemokine-1 (BAC-1) or B lymphocyte chemoattractant (BLC), CXCL13 serum levels were correlated with disease activity using the SLE Disease Activity Index (SLEDAI) and to lupus nephritis
Detailed description
Systemic lupus erythematosus (SLE) is systemic autoimmune disease characterized by various immunological abnormalities, including dysregulated activation of both T and B lymphocytes with overt production of autoreactive antibodies . Lupus nephritis (LN) is the most common and serious complication in SLE patients characterized by proteinuria, hematuria, drop glomerular filtration rate, or renal dysfunction . It is known that B lymphocytes are involved in the pathogenesis of systemic lupus erythematosus in autoantibody-dependent mechanisms . The chemokine CXC ligand 13 protein (CXCL13), also known as B cell-attracting chemokine-1 (BAC-1) or B lymphocyte chemoattractant (BLC), is a CXC subtype member of the chemokine superfamily. The receptor of CXCL13 is CXCR5, which is normally expressed on mature B cells and follicular T helper cells (Tfh). It has been demonstrated that CXCL13 is sufficient to induce secondary lymphoid tissues in peripheral organs. It is well known that different chemokines are involved in the pathogenesis of LN by orchestrating proinflammatory microenvironments, recruiting immune cell subsets into the kidney and by inducing local activation of immune effector cells . Local B-cell infiltration and related abnormal expression of ectopic lymphoid tissue (ELT) in the renal tissues of LN mice models was related to the severity of renal impairment .
Of interest, in regions of B cell infiltration a higher expression level of CXCL13 was found. Most B cells in this region expressed the corresponding receptor CXCR5, also supporting the hypothesis that CXCL13 induces B cell infiltration into the kidneys via its receptor CXCR5 .
In one study on 91Caucasian patients, CXCL13 serum levels were correlated with disease activity using the SLE Disease Activity Index (SLEDAI) and to lupus nephritis. It was found that serum CXCL13 levels correlated well with SLEDAI and median CXCL13 concentrations were higher in patients with renal involvement .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Diagnostic Test: blood samplespatients with SLE |
| controls | – | Diagnostic Test: blood samplesHealthy people |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- two groups: 46 patients with SLE 40 healthy people
Key inclusion criteria (1 listed)
- SLE patients diagnosed according to ACR
Key exclusion criteria (1 listed)
- patient with other autoimmune diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplesblood samples | Diagnostic test | cases, controls |
Primary outcome
to measure the level of cxcl13 in SLE
Time frame: Baseline
to differentiate the level of (cxcl13) between healthy individuals and patients with SLE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Background: PubMed 24878938Ahmadpoor P, Dalili N, Rostami M. An update on pathogenesis of systemic lupus erythematosus. Iran J Kidney Dis. 2014 May;8(3):171-84.
- Individual participant dataSharing planned: No
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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.
Wafaa El-Sherif, profeesor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus, run by Assiut 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 1 inclusion and 1 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 29 Jan 2019. 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 Mariam Mohamed, Master (+2001004519831, mariamnassar174@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to measure the level of cxcl13 in SLE (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03752983, which also lists 1 linked publication.
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 29 Jan 2019.