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/NCT05993052</url>
    </required_header>
    <id_info>
      <org_study_id>Carotid Doppler in MPNs</org_study_id>
      <nct_id>NCT05993052</nct_id>
    </id_info>
    <brief_title>Carotid Plaque Burden in Patients With Philadelphia Negative Myeloproliferative Neoplasms</brief_title>
    <official_title>Neutrophil-Lymphocyte Ratio and Carotid Plaque Burden in Patients With Philadelphia Negative Myeloproliferative Neoplasms and Their Relation to JAK2V617F Mutation</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>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>
        In around 90% of the patients with MPNs, an acquired mutation that promotes JAK/STAT&#xD;
        signaling is identified [3, 4]. The JAK/STAT pathway transduces signals from cytokines&#xD;
        including erythropoietin, thrombopoietin, and granulocyte colony-stimulating factor.24 A&#xD;
        point mutation that activates JAK2, JAK2V617F, is present in around 95% of patients with PV&#xD;
        and 40% to 60% of patients with ET and MF&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All patients will be subjected to a thorough assessment of history, complete clinical&#xD;
        examination, and investigations as complete blood picture including neutrophil-lymphocyte&#xD;
        ratio which will be analyzed with automated blood count analyzers, serum uric acid, serum&#xD;
        creatinine and lipid profile. All patients will undergo carotid imaging using Colour Doppler&#xD;
        ultrasonography for assessment of carotid plaque burden.&#xD;
  &#xD;
        The control group will undergo carotid ultrasonography who will be recruited among apparently&#xD;
        healthy volunteers aiming to match the patient group regarding age, sex and classical risk&#xD;
        factors for atherosclerosis as arterial hypertension, hyperlipidemia, diabetes, smoking or&#xD;
        obesity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 15, 2022</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">August 2023</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>Neutrophil-Lymphocyte Ratio in Patients with Philadelphia Negative Myeloproliferative Neoplasms</measure>
      <time_frame>baseline</time_frame>
      <description>All patients will be subjected to a thorough assessment of history, complete clinical examination, and investigations as complete blood picture including neutrophil-lymphocyte ratio which will be analyzed with automated blood count analyzers, serum uric acid, serum creatinine and lipid profile.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Carotid Plaque Burden in Patients with Philadelphia Negative Myeloproliferative Neoplasms</measure>
      <time_frame>baseline</time_frame>
      <description>All patients will undergo carotid imaging using Colour Doppler ultrasonography for assessment of carotid plaque burden. Extracranial carotid arteries were divided into three sectors on each side: common carotid artery and its bulb, internal carotid artery, and external carotid artery. At least one plaque in any sector was scored 1 point, while the absence of plaques was scored 0. Thus, the carotid plaque score ranged from 0 (absence of plaques) to 6 (plaques in all sectors)</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Myeloproliferative Neoplasm</condition>
    <eligibility>
      <study_pop>
        <textblock>
          patients with Philadelphia negative myeloproliferative neoplasms who were diagnosed&#xD;
          according to the WHO 2016 criteria, at Sohag university hospital, department of internal&#xD;
          medicine, hematology unit and hematology outpatient clinic.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients aged 18 years and older who were newly diagnosed to have Philadelphia&#xD;
               negative myeloproliferative neoplasms between September 2014 and November 2022 at&#xD;
               Sohag university hospital, department of internal medicine, hematology unit and&#xD;
               hematology outpatient clinic.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients were excluded if: (1) their disease of thrombocytosis or polycythemia was&#xD;
               determined to be reactive, (2) their disease was not newly diagnosed, (3) their&#xD;
               disease met WHO criteria for chronic or acute myeloid leukemia.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Mahmoud Gaber</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sohag University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mahmoud Gaber, dr</last_name>
      <phone>+201007399833</phone>
      <email>mahmoudgaber@med.sohag.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Medicine</name>
        <address>
          <city>Sohag</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mahmoud Gaber</last_name>
        <phone>+201007399833</phone>
        <email>mahmoudgaber@med.sohag.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Accorsi F. Color Doppler of the extracranial and intracranial arteries in the acute phase of cerebral ischemia. J Ultrasound. 2013 Sep 21;16(4):187-93. doi: 10.1007/s40477-013-0036-7. eCollection 2013 Sep 21.</citation>
      <PMID>24432173</PMID>
    </reference>
    <reference>
      <citation>Kralovics R, Passamonti F, Buser AS, Teo SS, Tiedt R, Passweg JR, Tichelli A, Cazzola M, Skoda RC. A gain-of-function mutation of JAK2 in myeloproliferative disorders. N Engl J Med. 2005 Apr 28;352(17):1779-90. doi: 10.1056/NEJMoa051113.</citation>
      <PMID>15858187</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Mahmoud Gaber Mahmoud</investigator_full_name>
      <investigator_title>Dr</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Myeloproliferative Disorders</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/NCT05993052
  org study id: Carotid Doppler in MPNs
  nct id: NCT05993052
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  In around 90% of the patients with MPNs, an acquired mutation that promotes JAK/STAT
        signaling is identified [3, 4]. The JAK/STAT pathway transduces signals from cytokines
        including erythropoietin, thrombopoietin, and granulocyte colony-stimulating factor.24 A
        point mutation that activates JAK2, JAK2V617F, is present in around 95% of patients with PV
        and 40% to 60% of patients with ET and MF
  All patients will be subjected to a thorough assessment of history, complete clinical
        examination, and investigations as complete blood picture including neutrophil-lymphocyte
        ratio which will be analyzed with automated blood count analyzers, serum uric acid, serum
        creatinine and lipid profile. All patients will undergo carotid imaging using Colour Doppler
        ultrasonography for assessment of carotid plaque burden.
  
        The control group will undergo carotid ultrasonography who will be recruited among apparently
        healthy volunteers aiming to match the patient group regarding age, sex and classical risk
        factors for atherosclerosis as arterial hypertension, hyperlipidemia, diabetes, smoking or
        obesity.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Neutrophil-Lymphocyte Ratio in Patients with Philadelphia Negative Myeloproliferative Neoplasms
  time frame: baseline
  description: All patients will be subjected to a thorough assessment of history, complete clinical examination, and investigations as complete blood picture including neutrophil-lymphocyte ratio which will be analyzed with automated blood count analyzers, serum uric acid, serum creatinine and lipid profile.
  measure: Carotid Plaque Burden in Patients with Philadelphia Negative Myeloproliferative Neoplasms
  time frame: baseline
  description: All patients will undergo carotid imaging using Colour Doppler ultrasonography for assessment of carotid plaque burden. Extracranial carotid arteries were divided into three sectors on each side: common carotid artery and its bulb, internal carotid artery, and external carotid artery. At least one plaque in any sector was scored 1 point, while the absence of plaques was scored 0. Thus, the carotid plaque score ranged from 0 (absence of plaques) to 6 (plaques in all sectors)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Mahmoud Gaber
  role: Principal Investigator
  affiliation: Sohag University
  last name: Mahmoud Gaber, dr
  phone: +201007399833
  email: mahmoudgaber@med.sohag.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Accorsi F. Color Doppler of the extracranial and intracranial arteries in the acute phase of cerebral ischemia. J Ultrasound. 2013 Sep 21;16(4):187-93. doi: 10.1007/s40477-013-0036-7. eCollection 2013 Sep 21.
  PMID: 24432173
  citation: Kralovics R, Passamonti F, Buser AS, Teo SS, Tiedt R, Passweg JR, Tichelli A, Cazzola M, Skoda RC. A gain-of-function mutation of JAK2 in myeloproliferative disorders. N Engl J Med. 2005 Apr 28;352(17):1779-90. doi: 10.1056/NEJMoa051113.
  PMID: 15858187
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Mahmoud Gaber Mahmoud
  investigator title: Dr
  mesh term: Neoplasms
  mesh term: Myeloproliferative Disorders