<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03752983</url>
  </required_header>
  <id_info>
    <org_study_id>CXCL13 in SLE</org_study_id>
    <nct_id>NCT03752983</nct_id>
  </id_info>
  <brief_title>Chemokine (CXCL13) as Anew Marker in Diagnosis of SLE</brief_title>
  <official_title>Chemokine CXCL13 as a Marker of Disease Activity in Systemic Lupus Erythematosus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Systemic lupus erythematosus (SLE) is systemic autoimmune disease characterized by various&#xD;
      immunological abnormalities, including dysregulated activation of both T and B lymphocytes&#xD;
      with overt production of autoreactive antibodies.The chemokine CXC ligand 13 protein&#xD;
      (CXCL13), also known as B cell-attracting chemokine-1 (BAC-1) or B lymphocyte chemoattractant&#xD;
      (BLC), CXCL13 serum levels were correlated with disease activity using the SLE Disease&#xD;
      Activity Index (SLEDAI) and to lupus nephritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Systemic lupus erythematosus (SLE) is systemic autoimmune disease characterized by various&#xD;
      immunological abnormalities, including dysregulated activation of both T and B lymphocytes&#xD;
      with overt production of autoreactive antibodies . Lupus nephritis (LN) is the most common&#xD;
      and serious complication in SLE patients characterized by proteinuria, hematuria, drop&#xD;
      glomerular filtration rate, or renal dysfunction . It is known that B lymphocytes are&#xD;
      involved in the pathogenesis of systemic lupus erythematosus in autoantibody-dependent&#xD;
      mechanisms . The chemokine CXC ligand 13 protein (CXCL13), also known as B cell-attracting&#xD;
      chemokine-1 (BAC-1) or B lymphocyte chemoattractant (BLC), is a CXC subtype member of the&#xD;
      chemokine superfamily. The receptor of CXCL13 is CXCR5, which is normally expressed on mature&#xD;
      B cells and follicular T helper cells (Tfh). It has been demonstrated that CXCL13 is&#xD;
      sufficient to induce secondary lymphoid tissues in peripheral organs. It is well known that&#xD;
      different chemokines are involved in the pathogenesis of LN by orchestrating proinflammatory&#xD;
      microenvironments, recruiting immune cell subsets into the kidney and by inducing local&#xD;
      activation of immune effector cells . Local B-cell infiltration and related abnormal&#xD;
      expression of ectopic lymphoid tissue (ELT) in the renal tissues of LN mice models was&#xD;
      related to the severity of renal impairment .&#xD;
&#xD;
      Of interest, in regions of B cell infiltration a higher expression level of CXCL13 was found.&#xD;
      Most B cells in this region expressed the corresponding receptor CXCR5, also supporting the&#xD;
      hypothesis that CXCL13 induces B cell infiltration into the kidneys via its receptor CXCR5 .&#xD;
&#xD;
      In one study on 91Caucasian patients, CXCL13 serum levels were correlated with disease&#xD;
      activity using the SLE Disease Activity Index (SLEDAI) and to lupus nephritis. It was found&#xD;
      that serum CXCL13 levels correlated well with SLEDAI and median CXCL13 concentrations were&#xD;
      higher in patients with renal involvement .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>to measure the level of cxcl13 in SLE</measure>
    <time_frame>Baseline</time_frame>
    <description>to differentiate the level of (cxcl13) between healthy individuals and patients with SLE</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Systemic Lupus</condition>
  <arm_group>
    <arm_group_label>cases</arm_group_label>
    <description>patients with SLE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <description>Healthy people</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>blood samples</intervention_name>
    <description>blood samples</description>
    <arm_group_label>cases</arm_group_label>
    <arm_group_label>controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        two groups: 46 patients with SLE 40 healthy people&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SLE patients diagnosed according to ACR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient with other autoimmune diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mariam Mohamed, Master</last_name>
    <phone>+2001004519831</phone>
    <email>mariamnassar174@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wafaa El-Sherif, profeesor</last_name>
    <phone>01001861515</phone>
    <phone_ext>+20</phone_ext>
  </overall_contact_backup>
  <reference>
    <citation>Ahmadpoor P, Dalili N, Rostami M. An update on pathogenesis of systemic lupus erythematosus. Iran J Kidney Dis. 2014 May;8(3):171-84.</citation>
    <PMID>24878938</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>January 27, 2019</last_update_submitted>
  <last_update_submitted_qc>January 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mariam Khamis Mohamed</investigator_full_name>
    <investigator_title>Assuit lecturer</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03752983
org study id: CXCL13 in SLE
nct id: NCT03752983
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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 .
observational model: Case-Control
time perspective: Retrospective
measure: to measure the level of cxcl13 in SLE
time frame: Baseline
description: to differentiate the level of (cxcl13) between healthy individuals and patients with SLE
arm group label: cases
description: patients with SLE
arm group label: controls
description: Healthy people
intervention type: Diagnostic Test
intervention name: blood samples
description: blood samples
arm group label: cases
arm group label: controls
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mariam Mohamed, Master
phone: +2001004519831
email: mariamnassar174@yahoo.com
last name: Wafaa El-Sherif, profeesor
phone: 01001861515
phone ext: +20
citation: Ahmadpoor P, Dalili N, Rostami M. An update on pathogenesis of systemic lupus erythematosus. Iran J Kidney Dis. 2014 May;8(3):171-84.
PMID: 24878938
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mariam Khamis Mohamed
investigator title: Assuit lecturer
sharing ipd: No