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

NCT ID: NCT05993065

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-15

Study Completion Date

2023-10-31

Brief Summary

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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

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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.

Conditions

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Polycythemia Vera

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Gaber Mahmoud

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Gaber

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

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Faculty of Medicine

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mahmoud Gaber

Role: CONTACT

+201007399833

Facility Contacts

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Mahmoud Gaber

Role: primary

+201007399833

References

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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.

Reference Type BACKGROUND
PMID: 27069254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33351130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33859172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33108020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25110547 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30478826 (View on PubMed)

Other Identifiers

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HCT to Hb and RDW in PV

Identifier Type: -

Identifier Source: org_study_id

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