Polycythemia VeraNCT05993065
Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis.
An observational study of Polycythemia Vera, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Sohag
Mahmoud Gaber, +201007399833, mahmoudgaber@med.sohag.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycythemia Vera
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Hematocrit to Hemoglobin Ratio in Polycythemia Vera and Secondary Erythrocytosis
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.
Measured: Patients will be collected from December 2022 to September 2023
Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis
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.
Measured: Patients will be collected from December 2022 to September 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start15 Dec 2022
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Gaber Mahmoud, Sohag University
- Investigators
- Mahmoud Gaber, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993065
- Sponsor's protocol ID
- HCT to Hb and RDW in PV
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27069254Wouters 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.
PubMed 33351130Nguyen 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.
PubMed 33859172Holik 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.
PubMed 33108020Bhatt 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.
PubMed 25110547McMullin 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.
PubMed 30478826
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hematocrit to Hemoglobin Ratio and Red Blood Cell Distribution Width in Polycythemia Vera and Secondary Erythrocytosis
- ClinicalTrials.gov ID
- NCT05993065
- Acronym / sponsor ID
- HCT to Hb and RDW in PV
- Conditions
- Polycythemia Vera
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 27069254Arber 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.
- Background: PubMed 33351130Wouters 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.
- Background: PubMed 33859172Nguyen 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.
- Background: PubMed 33108020Holik 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.
- Background: PubMed 25110547Bhatt 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.
- Background: PubMed 30478826McMullin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Gaber principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycythemia Vera, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Gaber (+201007399833, mahmoudgaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematocrit to Hemoglobin Ratio in Polycythemia Vera and Secondary Erythrocytosis (time frame: Patients will be collected from December 2022 to September 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05993065, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.