xml: <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/NCT06024486</url>
    </required_header>
    <id_info>
      <org_study_id>Juvenile arthritis assiut u</org_study_id>
      <nct_id>NCT06024486</nct_id>
    </id_info>
    <brief_title>Fibrinogen to Albumin Ratio and C-reactive Protein to Albumin Ratio in Juvenile Idiopathic Arthritis</brief_title>
    <official_title>Correlation of Fibrinogen to Albumin Ratio and C-reactive Protein to Albumin Ratio With Disease Activity in Juvenile Idiopathic Arthritis</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>
        The fibrinogen to albumin ratio (FAR) and C-reactive protein to albumin ratio (CAR) have&#xD;
        emerged as useful biomarkers to predict systemic inflammation. The aim here is to investigate&#xD;
        the relation between FAR/CAR and Juvenile arthritis disease activity score (JASDAS27) in&#xD;
        Juvenile idiopathic arthritis (JIA)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The JADAS27 includes a selected count of the following joints: cervical spine, elbows,&#xD;
        wrists, metacarpophalangeal joints (from first to third), proximal interphalangeal joints,&#xD;
        hips, knees and ankles.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The fibrinogen to albumin ratio</measure>
      <time_frame>3 months</time_frame>
      <description>measurement of serum fibrinogen and albumin</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The CRP to albumin ratio</measure>
      <time_frame>3 MONTHS</time_frame>
      <description>measurement of serum CRP and albumin</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlation of fibrinogen to albumin and CRP to albumin ratios on one side with disease activity on the other side</measure>
      <time_frame>3 MONTHS</time_frame>
      <description>correlation of these ratios with JADAS27</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Juvenile Idiopathic Arthritis</condition>
    <arm_group>
      <arm_group_label>JIA cases</arm_group_label>
      <description>juvenile idiopathic arthritis cases</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CONTROL</arm_group_label>
      <description>age and sex matched healthy controls</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>fibrinogen to albumin ratio (AFR) and C-reactive protein to albumin ratio (CAR)</intervention_name>
      <description>measurement of serum albumin, fibrinogen and CRP</description>
      <arm_group_label>CONTROL</arm_group_label>
      <arm_group_label>JIA cases</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All juvenile idiopathic arthritis fulfilling the criteria of International League of&#xD;
          Associations for Rheumatology (ILAR) and age and sex matched healthy subjects.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All juvenile idiopathic arthritis fulfilling the criteria of International League of&#xD;
               Associations for Rheumatology (ILAR) and age and sex matched healthy subjects&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other systemic inflammatory or autoimmune disorders.&#xD;
  &#xD;
            -  History of corticosteroid medication in the last 6 months.&#xD;
  &#xD;
            -  Liver diseases.&#xD;
  &#xD;
            -  Malignancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Maha Sayed Ibrahim Abdelrahman</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Arthritis, Juvenile</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024486
  org study id: Juvenile arthritis assiut u
  nct id: NCT06024486
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The fibrinogen to albumin ratio (FAR) and C-reactive protein to albumin ratio (CAR) have
        emerged as useful biomarkers to predict systemic inflammation. The aim here is to investigate
        the relation between FAR/CAR and Juvenile arthritis disease activity score (JASDAS27) in
        Juvenile idiopathic arthritis (JIA)
  The JADAS27 includes a selected count of the following joints: cervical spine, elbows,
        wrists, metacarpophalangeal joints (from first to third), proximal interphalangeal joints,
        hips, knees and ankles.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: The fibrinogen to albumin ratio
  time frame: 3 months
  description: measurement of serum fibrinogen and albumin
  measure: The CRP to albumin ratio
  time frame: 3 MONTHS
  description: measurement of serum CRP and albumin
  measure: Correlation of fibrinogen to albumin and CRP to albumin ratios on one side with disease activity on the other side
  time frame: 3 MONTHS
  description: correlation of these ratios with JADAS27
  arm group label: JIA cases
  description: juvenile idiopathic arthritis cases
  arm group label: CONTROL
  description: age and sex matched healthy controls
  intervention type: Diagnostic Test
  intervention name: fibrinogen to albumin ratio (AFR) and C-reactive protein to albumin ratio (CAR)
  description: measurement of serum albumin, fibrinogen and CRP
  arm group label: CONTROL
  arm group label: JIA cases
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 16 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Maha Sayed Ibrahim Abdelrahman
  investigator title: principal investigator
  mesh term: Arthritis
  mesh term: Arthritis, Juvenile