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Chemokine (CXCL13) as Anew Marker in Diagnosis of SLE

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ClinicalTrials.gov Identifier: NCT03752983
Recruitment Status : 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

Tracking Information
First Submitted Date November 22, 2018
First Posted Date November 26, 2018
Last Update Posted Date January 29, 2019
Estimated Study Start Date March 1, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 22, 2018)
to measure the level of cxcl13 in SLE [ Time Frame: Baseline ]
to differentiate the level of (cxcl13) between healthy individuals and patients with SLE
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03752983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chemokine (CXCL13) as Anew Marker in Diagnosis of SLE
Official Title Chemokine CXCL13 as a Marker of Disease Activity in Systemic Lupus Erythematosus
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
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population two groups: 46 patients with SLE 40 healthy people
Condition Systemic Lupus
Intervention Diagnostic Test: blood samples
blood samples
Study Groups/Cohorts
  • cases
    patients with SLE
    Intervention: Diagnostic Test: blood samples
  • controls
    Healthy people
    Intervention: Diagnostic Test: blood samples
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 22, 2018)
86
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • SLE patients diagnosed according to ACR

Exclusion Criteria:

  • patient with other autoimmune diseases.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mariam Mohamed, Master +2001004519831 mariamnassar174@yahoo.com
Contact: Wafaa El-Sherif, profeesor 01001861515 ext +20
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03752983
Other Study ID Numbers CXCL13 in SLE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mariam Khamis Mohamed, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date November 2018