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Chemokine (CXCL13) as Anew Marker in Diagnosis of SLE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03752983
Recruitment Status : Unknown
Verified November 2018 by Mariam Khamis Mohamed, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : November 26, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Mariam Khamis Mohamed, Assiut University

Study Description
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Brief 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 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

Condition or disease Intervention/treatment
Systemic Lupus Diagnostic Test: blood samples

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
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Study Type : Observational
Estimated Enrollment : 86 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Chemokine CXCL13 as a Marker of Disease Activity in Systemic Lupus Erythematosus
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : December 1, 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
cases
patients with SLE
 Diagnostic Test: blood samples
blood samples
controls
Healthy people
 Diagnostic Test: blood samples
blood samples


Outcome Measures
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Primary Outcome Measures :
  1. to measure the level of cxcl13 in SLE [ Time Frame: Baseline ]
    to differentiate the level of (cxcl13) between healthy individuals and patients with SLE


Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
two groups: 46 patients with SLE 40 healthy people
Criteria

Inclusion Criteria:

  • SLE patients diagnosed according to ACR

Exclusion Criteria:

  • patient with other autoimmune diseases.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752983


Contacts
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Contact: Mariam Mohamed, Master +2001004519831 mariamnassar174@yahoo.com
Contact: Wafaa El-Sherif, profeesor 01001861515 ext +20

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Mariam Khamis Mohamed, Assuit lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03752983    
Other Study ID Numbers: CXCL13 in SLE
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No