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Trial Title:
Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis.
NCT ID:
NCT05993065
Condition:
Polycythemia Vera
Conditions: Official terms:
Polycythemia Vera
Polycythemia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
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.
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Faculty of Medicine
Address:
City:
Sohag
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Mahmoud Gaber
Phone:
+201007399833
Email:
mahmoudgaber@med.sohag.edu.eg
Start date:
December 15, 2022
Completion date:
October 2023
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05993065
