Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis.

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05993065
Collaborator
(none)
100
1
9.5
10.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Study of Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis
    Actual Study Start Date :
    Dec 15, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    polycythemia vera

    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.

    secondary erythrocytosis

    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

    Outcome Measures

    Primary Outcome Measures

    1. Hematocrit to Hemoglobin Ratio in Polycythemia Vera and Secondary Erythrocytosis [Patients will be collected from December 2022 to September 2023]

      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.

    2. Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis [Patients will be collected from December 2022 to September 2023]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:
    • Patients were excluded if: (1) their disease was not newly diagnosed, (2) their disease met WHO criteria for chronic, acute myeloid leukemia or other myeloid neoplasms.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    • Principal Investigator: Mahmoud Gaber, Sohag University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mahmoud Gaber Mahmoud, Dr, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05993065
    Other Study ID Numbers:
    • HCT to Hb and RDW in PV
    First Posted:
    Aug 15, 2023
    Last Update Posted:
    Aug 15, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 15, 2023