Clinical trial NCT05993065: Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis.
Official title: Study of Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycythemia Vera
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: Hematocrit to Hemoglobin Ratio in Polycythemia Vera and Secondary Erythrocytosis
timeFrame: Patients will be collected from December 2022 to September 2023
measure: Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis
timeFrame: Patients will be collected from December 2022 to September 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Sohag University
name: Mahmoud Gaber
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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: 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: 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.