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

August 12, 2023 updated by: Mahmoud Gaber Mahmoud, Sohag University

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with polycythemia vera who were diagnosed according to the WHO 2016 criteria, at Sohag university hospital, department of internal medicine, hematology unit and hematology outpatient clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematocrit to Hemoglobin Ratio in Polycythemia Vera and Secondary Erythrocytosis
Time Frame: 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.
Patients will be collected from December 2022 to September 2023
Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis
Time Frame: 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.
Patients will be collected from December 2022 to September 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Mahmoud Gaber, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

August 6, 2023

First Submitted That Met QC Criteria

August 12, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCT to Hb and RDW in PV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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