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/NCT05997108</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-07-01MS</org_study_id>
      <nct_id>NCT05997108</nct_id>
    </id_info>
    <brief_title>Platelet and Red Blood Cell Volume Indices as Inflammatory Biomarkers in Ankylosing Spondylitis</brief_title>
    <official_title>Platelet and Red Blood Cell Volume Indices as Inflammatory Biomarkers in Ankylosing Spodylitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</source>
    <oversight_info>
      <has_dmc>No</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>
        this study aims to determine the relatioships among the NLR ,PLR ,MLR ,red cell volume and&#xD;
        platelet volume indices levels as biomarkers in ankylosing spondylitis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>platelet</measure>
      <time_frame>6 months</time_frame>
      <description>platelet cell volume indices</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Red blood cell</measure>
      <time_frame>6 months</time_frame>
      <description>red blood cell volume indices</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Ankylosing Spondylitis</condition>
    <arm_group>
      <arm_group_label>cases group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>CBC</intervention_name>
      <description>Platelet and red blood cell volume indices</description>
      <arm_group_label>cases group</arm_group_label>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          PATIENT WITH DISEASE DURATION OF MORE THAN 6 MONTHS&#xD;
  &#xD;
          -AGE MORE THAN 18 YEARS&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  PATIENT WITH DISEASE DURATION OF MORE THAN 6 MONTHS&#xD;
  &#xD;
            -  AGE MORE THAN 18 YEARS&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  PATIENT WITH CARDIAC ,CEREBROVASCULAR AND HEMATOLOGIC DIEASE&#xD;
  &#xD;
            -  PTIENT WITH HYPERTENSION ,DIABETES ,METABOLIS SYNDROMES AND OTHER AUTOIMMUNE RHEUMATIC&#xD;
               DISEASES.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>MARGO G MOFEED, resident</last_name>
      <phone>01276496930</phone>
      <email>MARGO-GERGES-POST@MED.SOHAG.EDU.EG</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>MOHAMMED A ESMAIL, assistant professor</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sohag university Hospital</name>
        <address>
          <city>Sohag</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Magdy M Amin, professor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Azab B, Torbey E, Singh J, Akerman M, Khoueiry G, McGinn JT, Widmann WD, Lafferty J. Mean platelet volume/platelet count ratio as a predictor of long-term mortality after non-ST-elevation myocardial infarction. Platelets. 2011;22(8):557-66. doi: 10.3109/09537104.2011.584086. Epub 2011 Jun 30.</citation>
      <PMID>21714700</PMID>
    </reference>
    <reference>
      <citation>Coutant F, Miossec P. Evolving concepts of the pathogenesis of rheumatoid arthritis with focus on the early and late stages. Curr Opin Rheumatol. 2020 Jan;32(1):57-63. doi: 10.1097/BOR.0000000000000664.</citation>
      <PMID>31644463</PMID>
    </reference>
    <reference>
      <citation>Bekdas M, Goksugur SB, Sarac EG, Erkocoglu M, Demircioglu F. Neutrophil/lymphocyte and C-reactive protein/mean platelet volume ratios in differentiating between viral and bacterial pneumonias and diagnosing early complications in children. Saudi Med J. 2014 May;35(5):442-7.</citation>
      <PMID>24825803</PMID>
    </reference>
    <reference>
      <citation>Kumano Y, Hasegawa Y, Kawahara T, Yasui M, Miyoshi Y, Matsubara N, Uemura H. Pretreatment Neutrophil to Lymphocyte Ratio (NLR) Predicts Prognosis for Castration Resistant Prostate Cancer Patients Underwent Enzalutamide. Biomed Res Int. 2019 Jan 20;2019:9450838. doi: 10.1155/2019/9450838. eCollection 2019.</citation>
      <PMID>30800682</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Margo Gerges Mofeed</investigator_full_name>
      <investigator_title>Resident-rheumatology department-sohag general hospital</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spondylitis</mesh_term>
      <mesh_term>Spondylarthritis</mesh_term>
      <mesh_term>Spondylitis, Ankylosing</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/NCT05997108
  org study id: Soh-Med-23-07-01MS
  nct id: NCT05997108
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  this study aims to determine the relatioships among the NLR ,PLR ,MLR ,red cell volume and
        platelet volume indices levels as biomarkers in ankylosing spondylitis.
  observational model: Case-Control
  time perspective: Retrospective
  measure: platelet
  time frame: 6 months
  description: platelet cell volume indices
  measure: Red blood cell
  time frame: 6 months
  description: red blood cell volume indices
  arm group label: cases group
  arm group label: control group
  intervention type: Diagnostic Test
  intervention name: CBC
  description: Platelet and red blood cell volume indices
  arm group label: cases group
  arm group label: control group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: MARGO G MOFEED, resident
  phone: 01276496930
  email: MARGO-GERGES-POST@MED.SOHAG.EDU.EG
  last name: MOHAMMED A ESMAIL, assistant professor
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Azab B, Torbey E, Singh J, Akerman M, Khoueiry G, McGinn JT, Widmann WD, Lafferty J. Mean platelet volume/platelet count ratio as a predictor of long-term mortality after non-ST-elevation myocardial infarction. Platelets. 2011;22(8):557-66. doi: 10.3109/09537104.2011.584086. Epub 2011 Jun 30.
  PMID: 21714700
  citation: Coutant F, Miossec P. Evolving concepts of the pathogenesis of rheumatoid arthritis with focus on the early and late stages. Curr Opin Rheumatol. 2020 Jan;32(1):57-63. doi: 10.1097/BOR.0000000000000664.
  PMID: 31644463
  citation: Bekdas M, Goksugur SB, Sarac EG, Erkocoglu M, Demircioglu F. Neutrophil/lymphocyte and C-reactive protein/mean platelet volume ratios in differentiating between viral and bacterial pneumonias and diagnosing early complications in children. Saudi Med J. 2014 May;35(5):442-7.
  PMID: 24825803
  citation: Kumano Y, Hasegawa Y, Kawahara T, Yasui M, Miyoshi Y, Matsubara N, Uemura H. Pretreatment Neutrophil to Lymphocyte Ratio (NLR) Predicts Prognosis for Castration Resistant Prostate Cancer Patients Underwent Enzalutamide. Biomed Res Int. 2019 Jan 20;2019:9450838. doi: 10.1155/2019/9450838. eCollection 2019.
  PMID: 30800682
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Margo Gerges Mofeed
  investigator title: Resident-rheumatology department-sohag general hospital
  mesh term: Spondylitis
  mesh term: Spondylarthritis
  mesh term: Spondylitis, Ankylosing