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/NCT05993065</url>
    </required_header>
    <id_info>
      <org_study_id>HCT to Hb and RDW in PV</org_study_id>
      <nct_id>NCT05993065</nct_id>
    </id_info>
    <brief_title>Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis.</brief_title>
    <official_title>Study of Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis</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>
        Polycythemia vera (PV), a hematological neoplasm characterized by excessive erythropoiesis&#xD;
        due to Janus kinase 2 (JAK2)- activating mutations. On the other hand, patients with&#xD;
        secondary polycythemia (SP), a disorder mostly caused by an increased red cell mass due to&#xD;
        chronic hypoxia (i.e, pulmonary disorders and smoking) and erythropoietin-producing tumors&#xD;
        (such as leiomyoma, hemangiomas, renal cysts and various carcinomas), are phenotypically&#xD;
        slightly different and are usually considered to have significantly better outcomes.&#xD;
  &#xD;
        Red blood cell distribution width (RDW) reflects the heterogeneity of red blood cell sizes&#xD;
        (anisocytosis) and is routinely reported as a part of complete blood count by automated&#xD;
        instruments in hematology laboratories.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        We will collect data about clinical manifestations at the time of diagnosis, history of&#xD;
        thrombosis and investigations as complete blood picture, including Hematocrit and haemoglobin&#xD;
        level, serum uric acid, JAK2V617F mutation status by real time PCR (Polymerase Chain&#xD;
        Reaction), bone marrow aspiration and biopsy with reticulin stain.&#xD;
  &#xD;
        Patients with secondary erythrocytosis will be included as controls and will be recruited&#xD;
        from Sohag university hospital especially internal medicine department and chest department.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 15, 2022</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">September 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>Hematocrit to Hemoglobin Ratio in Polycythemia Vera and Secondary Erythrocytosis</measure>
      <time_frame>Patients will be collected from December 2022 to September 2023</time_frame>
      <description>We will collect data about clinical manifestations at the time of diagnosis, history of thrombosis and investigations as complete blood picture, including Hematocrit and haemoglobin level, serum uric acid, JAK2V617F mutation status by real time PCR (Polymerase Chain Reaction), bone marrow aspiration and biopsy with reticulin stain.&#xD;
  Patients with secondary erythrocytosis will be included as controls and will be recruited from Sohag university hospital especially internal medicine department and chest department.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis</measure>
      <time_frame>Patients will be collected from December 2022 to September 2023</time_frame>
      <description>We will collect data about clinical manifestations at the time of diagnosis, history of thrombosis and investigations as complete blood picture, including Red Blood Cell Distribution Width, serum uric acid, JAK2V617F mutation status by real time PCR (Polymerase Chain Reaction), bone marrow aspiration and biopsy with reticulin stain.&#xD;
  Patients with secondary erythrocytosis will be included as controls and will be recruited from Sohag university hospital especially internal medicine department and chest department.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Polycythemia Vera</condition>
    <arm_group>
      <arm_group_label>polycythemia vera</arm_group_label>
      <description>All patients aged 18 years and older who were newly diagnosed to have polycythemia vera between September 2014 and November 2022 at Sohag university hospital, department of internal medicine, hematology unit and hematology outpatient clinic.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>secondary erythrocytosis</arm_group_label>
      <description>Patients with secondary erythrocytosis will be included as controls and will be recruited from Sohag university hospital especially internal medicine department and chest department. Patients of chronic respiratory failure, congenital heart diseases, polycystic kidney and other causes recruited in this study to be compared to PV group as regards Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          patients with polycythemia vera who were diagnosed according to the WHO 2016 criteria, at&#xD;
          Sohag university hospital, department of internal medicine, hematology unit and hematology&#xD;
          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 polycythemia&#xD;
               vera between September 2014 and November 2022 at Sohag university hospital, department&#xD;
               of internal medicine, hematology unit and hematology outpatient clinic.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients were excluded if: (1) their disease was not newly diagnosed, (2) their&#xD;
               disease met WHO criteria for chronic, acute myeloid leukemia or other myeloid&#xD;
               neoplasms.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </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</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>Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11.</citation>
      <PMID>27069254</PMID>
    </reference>
    <reference>
      <citation>Wouters HJCM, Mulder R, van Zeventer IA, Schuringa JJ, van der Klauw MM, van der Harst P, Diepstra A, Mulder AB, Huls G. Erythrocytosis in the general population: clinical characteristics and association with clonal hematopoiesis. Blood Adv. 2020 Dec 22;4(24):6353-6363. doi: 10.1182/bloodadvances.2020003323.</citation>
      <PMID>33351130</PMID>
    </reference>
    <reference>
      <citation>Nguyen E, Harnois M, Busque L, Sirhan S, Assouline S, Chamaki I, Olney H, Mollica L, Szuber N. Phenotypical differences and thrombosis rates in secondary erythrocytosis versus polycythemia vera. Blood Cancer J. 2021 Apr 15;11(4):75. doi: 10.1038/s41408-021-00463-x. No abstract available.</citation>
      <PMID>33859172</PMID>
    </reference>
    <reference>
      <citation>Holik H, Krecak I, Gveric-Krecak V, Vucinic Ljubicic I, Coha B. Higher red blood cell distribution width might differentiate primary from secondary polycythemia: A pilot study. Int J Lab Hematol. 2021 Apr;43(2):e68-e71. doi: 10.1111/ijlh.13373. Epub 2020 Oct 27. No abstract available.</citation>
      <PMID>33108020</PMID>
    </reference>
    <reference>
      <citation>Bhatt VR. Secondary polycythemia and the risk of venous thromboembolism. J Clin Med Res. 2014 Oct;6(5):395-7. doi: 10.14740/jocmr1916w. Epub 2014 Jul 28. No abstract available.</citation>
      <PMID>25110547</PMID>
    </reference>
    <reference>
      <citation>McMullin MF, Harrison CN, Ali S, Cargo C, Chen F, Ewing J, Garg M, Godfrey A, S SK, McLornan DP, Nangalia J, Sekhar M, Wadelin F, Mead AJ; BSH Committee. A guideline for the diagnosis and management of polycythaemia vera. A British Society for Haematology Guideline. Br J Haematol. 2019 Jan;184(2):176-191. doi: 10.1111/bjh.15648. Epub 2018 Nov 27. No abstract available. Erratum In: Br J Haematol. 2019 Apr;185(1):198.</citation>
      <PMID>30478826</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 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>Polycythemia Vera</mesh_term>
      <mesh_term>Polycythemia</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/NCT05993065
  org study id: HCT to Hb and RDW in PV
  nct id: NCT05993065
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Polycythemia vera (PV), a hematological neoplasm characterized by excessive erythropoiesis
        due to Janus kinase 2 (JAK2)- activating mutations. On the other hand, patients with
        secondary polycythemia (SP), a disorder mostly caused by an increased red cell mass due to
        chronic hypoxia (i.e, pulmonary disorders and smoking) and erythropoietin-producing tumors
        (such as leiomyoma, hemangiomas, renal cysts and various carcinomas), are phenotypically
        slightly different and are usually considered to have significantly better outcomes.
  
        Red blood cell distribution width (RDW) reflects the heterogeneity of red blood cell sizes
        (anisocytosis) and is routinely reported as a part of complete blood count by automated
        instruments in hematology laboratories.
  We will collect data about clinical manifestations at the time of diagnosis, history of
        thrombosis and investigations as complete blood picture, including Hematocrit and haemoglobin
        level, serum uric acid, JAK2V617F mutation status by real time PCR (Polymerase Chain
        Reaction), bone marrow aspiration and biopsy with reticulin stain.
  
        Patients with secondary erythrocytosis will be included as controls and will be recruited
        from Sohag university hospital especially internal medicine department and chest department.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Hematocrit to Hemoglobin Ratio in Polycythemia Vera and Secondary Erythrocytosis
  time frame: Patients will be collected from December 2022 to September 2023
  description: We will collect data about clinical manifestations at the time of diagnosis, history of thrombosis and investigations as complete blood picture, including Hematocrit and haemoglobin level, serum uric acid, JAK2V617F mutation status by real time PCR (Polymerase Chain Reaction), bone marrow aspiration and biopsy with reticulin stain.
  Patients with secondary erythrocytosis will be included as controls and will be recruited from Sohag university hospital especially internal medicine department and chest department.
  measure: Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis
  time frame: Patients will be collected from December 2022 to September 2023
  description: We will collect data about clinical manifestations at the time of diagnosis, history of thrombosis and investigations as complete blood picture, including Red Blood Cell Distribution Width, serum uric acid, JAK2V617F mutation status by real time PCR (Polymerase Chain Reaction), bone marrow aspiration and biopsy with reticulin stain.
  Patients with secondary erythrocytosis will be included as controls and will be recruited from Sohag university hospital especially internal medicine department and chest department.
  arm group label: polycythemia vera
  description: All patients aged 18 years and older who were newly diagnosed to have polycythemia vera between September 2014 and November 2022 at Sohag university hospital, department of internal medicine, hematology unit and hematology outpatient clinic.
  arm group label: secondary erythrocytosis
  description: Patients with secondary erythrocytosis will be included as controls and will be recruited from Sohag university hospital especially internal medicine department and chest department. Patients of chronic respiratory failure, congenital heart diseases, polycystic kidney and other causes recruited in this study to be compared to PV group as regards Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mahmoud Gaber
  role: Principal Investigator
  affiliation: Sohag University
  last name: Mahmoud Gaber
  phone: +201007399833
  email: mahmoudgaber@med.sohag.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11.
  PMID: 27069254
  citation: Wouters HJCM, Mulder R, van Zeventer IA, Schuringa JJ, van der Klauw MM, van der Harst P, Diepstra A, Mulder AB, Huls G. Erythrocytosis in the general population: clinical characteristics and association with clonal hematopoiesis. Blood Adv. 2020 Dec 22;4(24):6353-6363. doi: 10.1182/bloodadvances.2020003323.
  PMID: 33351130
  citation: Nguyen E, Harnois M, Busque L, Sirhan S, Assouline S, Chamaki I, Olney H, Mollica L, Szuber N. Phenotypical differences and thrombosis rates in secondary erythrocytosis versus polycythemia vera. Blood Cancer J. 2021 Apr 15;11(4):75. doi: 10.1038/s41408-021-00463-x. No abstract available.
  PMID: 33859172
  citation: Holik H, Krecak I, Gveric-Krecak V, Vucinic Ljubicic I, Coha B. Higher red blood cell distribution width might differentiate primary from secondary polycythemia: A pilot study. Int J Lab Hematol. 2021 Apr;43(2):e68-e71. doi: 10.1111/ijlh.13373. Epub 2020 Oct 27. No abstract available.
  PMID: 33108020
  citation: Bhatt VR. Secondary polycythemia and the risk of venous thromboembolism. J Clin Med Res. 2014 Oct;6(5):395-7. doi: 10.14740/jocmr1916w. Epub 2014 Jul 28. No abstract available.
  PMID: 25110547
  citation: McMullin MF, Harrison CN, Ali S, Cargo C, Chen F, Ewing J, Garg M, Godfrey A, S SK, McLornan DP, Nangalia J, Sekhar M, Wadelin F, Mead AJ; BSH Committee. A guideline for the diagnosis and management of polycythaemia vera. A British Society for Haematology Guideline. Br J Haematol. 2019 Jan;184(2):176-191. doi: 10.1111/bjh.15648. Epub 2018 Nov 27. No abstract available. Erratum In: Br J Haematol. 2019 Apr;185(1):198.
  PMID: 30478826
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Mahmoud Gaber Mahmoud
  investigator title: Dr
  mesh term: Polycythemia Vera
  mesh term: Polycythemia