ErythrocytosisEVERESTNCT06785870
EVAluation of Erythrocytosis PRospEctive Cohort STudy
An observational study of Erythrocytosis and Polycythemia, run by Cyrus Hsia at 1 site in Canada.
Trial summary
The EValuation of ERythrocytosis pRospEctive cohort STudy (EVEREST) is a prospective study designed to shed light on these key questions in the diagnosis, management, and clinical outcomes in patients with elevated hemoglobin (erythrocytosis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythrocytosis, Polycythemia, Polycythemia Secondary
- How many people
- 1,500 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2025to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: EVEREST will recruit adult patients evaluated for erythrocytosis, hemoglobin levels >=165 g/L in males or >=160 g/L in females, in hematology clinics at London Health Sciences Centre.
Who may be able to join
- Adult patients (>=18 years) referred to hematology clinics at London Health Sciences Centre with hemoglobin levels >=165 g/L in males or >=160 g/L in females.
- Patients capable of providing informed consent.
- Age >= 18 years.
Who cannot join
- Patients <18 years.
- Patients without erythrocytosis.
- Patients incapable of providing informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Victoria Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9
Cyrus C. Hsia, MD, FRCPC, 1-519-685-8500 ext. 56060, cyrus.hsia@lhsc.on.ca
Benjamin Chin-Yee, MD, FRCPC, 1-519-685-8718, benjamin.chin-yee@lhsc.on.ca
About this study
Official title: Evaluation of Erythrocytosis Prospective Cohort Study (EVEREST): Diagnosis, Management and Longitudinal Outcomes in Patients with Elevated Hemoglobin
The EValuation of ERythrocytosis pRospEctive cohort STudy (EVEREST) is a prospective study designed to shed light on these key questions in the diagnosis, management, and clinical outcomes in patients with elevated hemoglobin (erythrocytosis). This longitudinal, prospective study will generate high quality data that can help inform the optimal approach to diagnosis and management in this patient population.
Read the detailed description
The EVAluation of Erythrocytosis pRospEctive cohort STudy (EVEREST) is a prospective, longitudinal, observational study designed to provide insights into the diagnosis, management, and outcomes of patients with elevated hemoglobin (erythrocytosis). This study aims to address key gaps in understanding the underlying causes, diagnostic approaches, and clinical outcomes of patients presenting with erythrocytosis in real-world clinical settings.
Erythrocytosis, defined as an elevated hemoglobin concentration, is a frequent reason for referral to hematology and presents substantial diagnostic and therapeutic challenges. The condition may arise from primary causes, such as polycythemia vera (PV), or secondary causes, including chronic hypoxia, erythropoietin-secreting tumors, medications, and exogenous testosterone use. Despite advances in diagnostic tools, there remains considerable uncertainty about the most effective ways to evaluate and manage erythrocytosis, particularly in distinguishing secondary from primary causes and in mitigating associated risks such as arterial and venous thrombosis.
EVEREST is designed to address these knowledge gaps by enrolling a diverse cohort of patients referred to hematology for evaluation of erythrocytosis. Participants will undergo comprehensive clinical evaluation and assessment of potential underlying causes. Data will be collected longitudinally to evaluate real-world management practices, such as the use of phlebotomy, cytoreductive therapy, and antithrombotic agents, and to document clinical outcomes, including rates of thrombosis, bleeding, disease progression, and mortality.
The study has four main objectives:
- To prospectively measure the incidence of various causes of erythrocytosis in patients referred for elevated hemoglobin levels.
- To prospectively evaluate the diagnostic accuracy of the JAKPOT prediction rule, a simple prediction rule using complete blood count parameters, for identifying JAK2-positive erythrocytosis/polycythemia vera and differentiating it from secondary causes.
- To evaluate real-world management strategies for patients with erythrocytosis.
- To document longitudinal clinical outcomes, including thrombosis, bleeding, disease progression, and survival.
EVEREST aims to recruit 1,500 adult patients across participating clinics. Participants will be followed for clinical outcomes, and data will be collected to better characterize therapeutic approaches utilized in routine clinical care. This study seeks to generate evidence that will inform clinical practice and improve patient care for patients with erythrocytosis.
Outcome Measures EVEREST is a prospective observational study which will investigate multiple interrelated aspects of erythrocytosis, encompassing its causes, diagnostic evaluation, management strategies, and clinical outcomes. Two co-primary outcome measures have been selected to reflect the study's main objectives to measure the incidence and causes of erythrocytosis and the diagnostic accuracy of the JAKPOT prediction rule. Additionally, secondary outcome measures will focus on real-world management strategies and longitudinal clinical outcomes, providing further insights to inform patient care.
- Conditions
- Erythrocytosis, Polycythemia, Polycythemia Secondary, Polycythemia Vera, Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase, Polycythemia Vera (PV)
- Keywords
- Prospective, Observational Study, Erythrocytosis, Polycythemia, Patient Registry, Diagnosis, Management, Outcomes
- Medical subject headings
- Polycythemia, Polycythemia Vera, Polycythemia, primary familial and congenital, Disease
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 |
|---|---|---|
| Erythrocytosis patients | Adult patients (>=18 years) referred to hematology clinics at London Health Sciences Centre (LHSC) with erythrocytosis or polycythemia with hemoglobin levels >=165 g/L in males or >=160 g/L in females at the time of initial clinic visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Causes of Erythrocytosis
The study will measure the incidence of primary and secondary causes of erythrocytosis, including polycythemia vera (PV), chronic hypoxia, medication use (e.g., SGLT2 inhibitors, testosterone), and other secondary causes. Data will be derived from clinical records and diagnostic investigations conducted as part of routine care.
Unit of Measure: Proportion of participants (%) and count (n) categorized by cause over the study duration.
Measured: 5 years
Diagnostic Accuracy of the JAKPOT Prediction Rule
The diagnostic accuracy of the JAKPOT prediction rule will be assessed for differentiating JAK2-positive erythrocytosis/PV from other causes. Measures will include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Unit of Measure: Sensitivity (%), specificity (%), PPV (%), and NPV (%).
Measured: 5 years
Secondary outcomes (5)
Frequency of Management Strategies
The study will document the proportion of participants receiving various management strategies, including phlebotomy, cytoreductive therapy, antiplatelet agents (e.g., aspirin), and anticoagulants. Data will include timing, frequency, and type of intervention, as recorded in clinical records.
Unit of Measure: Proportion of participants (%) and count (n) receiving each management strategy.
Measured: 5 years
Incidence of Thrombotic Events
Thrombotic events, including venous thromboembolism (deep vein thrombosis, pulmonary embolism) and arterial thrombosis (ischemic stroke, myocardial infarction), will be documented based on clinical records and imaging results. Standard definitions will be applied for classification.
Unit of Measure: Events per 100 person-years.
Measured: 5 years
Incidence of Bleeding Events
Bleeding events, categorized as major or clinically relevant non-major bleeding following ISTH definitions, will be measured. Data will include site, severity, and clinical consequences of bleeding.
Unit of Measure: Events per 100 person-years.
Measured: 5 years
Disease Progression
Disease progression, defined as transformation to myeloproliferative neoplasms (e.g., myelofibrosis, myelodysplastic syndrome, acute leukemia) or other hematologic malignancies, will be captured. Progression will be classified using WHO criteria and supported by clinical and laboratory data.
Unit of Measure: Incidence per 100 person-years.
Measured: 5 years
Mortality
Mortality data will include all-cause and cause-specific deaths, categorized as cardiovascular-related, thrombotic, hemorrhagic, or due to disease progression. Cause-specific data will be confirmed by clinical documentation or autopsy reports where available.
Unit of Measure: Incidence per 100 person-years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythrocytosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Cyrus Hsia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cyrus Hsia, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785870
- Sponsor's protocol ID
- HSREB125939
- Acronym
- EVEREST
- Status last verified
- Jan 2025
- First submitted
- 15 Sep 2024
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Erythrocytosis Prospective Cohort Study (EVEREST): Diagnosis, Management and Longitudinal Outcomes in Patients with Elevated Hemoglobin
- ClinicalTrials.gov ID
- NCT06785870
- Acronym / sponsor ID
- EVEREST / HSREB125939
- Conditions
- Erythrocytosis, Polycythemia, Polycythemia Secondary, Polycythemia Vera, Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase, Polycythemia Vera (PV)
- Keywords
- Prospective, Observational Study, Erythrocytosis, Polycythemia, Patient Registry, Diagnosis, Management, Outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Cyrus HsiaUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Jan 2025 (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.
The EValuation of ERythrocytosis pRospEctive cohort STudy (EVEREST) is a prospective study designed to shed light on these key questions in the diagnosis, management, and clinical outcomes in patients with elevated hemoglobin (erythrocytosis). This longitudinal, prospective study will generate high quality data that can help inform the optimal approach to diagnosis and management in this patient population.
Detailed description
The EVAluation of Erythrocytosis pRospEctive cohort STudy (EVEREST) is a prospective, longitudinal, observational study designed to provide insights into the diagnosis, management, and outcomes of patients with elevated hemoglobin (erythrocytosis). This study aims to address key gaps in understanding the underlying causes, diagnostic approaches, and clinical outcomes of patients presenting with erythrocytosis in real-world clinical settings.
Erythrocytosis, defined as an elevated hemoglobin concentration, is a frequent reason for referral to hematology and presents substantial diagnostic and therapeutic challenges. The condition may arise from primary causes, such as polycythemia vera (PV), or secondary causes, including chronic hypoxia, erythropoietin-secreting tumors, medications, and exogenous testosterone use. Despite advances in diagnostic tools, there remains considerable uncertainty about the most effective ways to evaluate and manage erythrocytosis, particularly in distinguishing secondary from primary causes and in mitigating associated risks such as arterial and venous thrombosis.
EVEREST is designed to address these knowledge gaps by enrolling a diverse cohort of patients referred to hematology for evaluation of erythrocytosis. Participants will undergo comprehensive clinical evaluation and assessment of potential underlying causes. Data will be collected longitudinally to evaluate real-world management practices, such as the use of phlebotomy, cytoreductive therapy, and antithrombotic agents, and to document clinical outcomes, including rates of thrombosis, bleeding, disease progression, and mortality.
The study has four main objectives:
- To prospectively measure the incidence of various causes of erythrocytosis in patients referred for elevated hemoglobin levels.
- To prospectively evaluate the diagnostic accuracy of the JAKPOT prediction rule, a simple prediction rule using complete blood count parameters, for identifying JAK2-positive erythrocytosis/polycythemia vera and differentiating it from secondary causes.
- To evaluate real-world management strategies for patients with erythrocytosis.
- To document longitudinal clinical outcomes, including thrombosis, bleeding, disease progression, and survival.
EVEREST aims to recruit 1,500 adult patients across participating clinics. Participants will be followed for clinical outcomes, and data will be collected to better characterize therapeutic approaches utilized in routine clinical care. This study seeks to generate evidence that will inform clinical practice and improve patient care for patients with erythrocytosis.
Outcome Measures EVEREST is a prospective observational study which will investigate multiple interrelated aspects of erythrocytosis, encompassing its causes, diagnostic evaluation, management strategies, and clinical outcomes. Two co-primary outcome measures have been selected to reflect the study's main objectives to measure the incidence and causes of erythrocytosis and the diagnostic accuracy of the JAKPOT prediction rule. Additionally, secondary outcome measures will focus on real-world management strategies and longitudinal clinical outcomes, providing further insights to inform patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erythrocytosis patients | – | –Adult patients (>=18 years) referred to hematology clinics at London Health Sciences Centre (LHSC) with erythrocytosis or polycythemia with hemoglobin levels >=165 g/L in males or >=160 g/L in females at the time of initial clinic visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- EVEREST will recruit adult patients evaluated for erythrocytosis, hemoglobin levels >=165 g/L in males or >=160 g/L in females, in hematology clinics at London Health Sciences Centre.
Key inclusion criteria (3 listed)
- Adult patients (>=18 years) referred to hematology clinics at London Health Sciences Centre with hemoglobin levels >=165 g/L in males or >=160 g/L in females.
- Patients capable of providing informed consent.
- Age >= 18 years.
Key exclusion criteria (3 listed)
- Patients <18 years.
- Patients without erythrocytosis.
- Patients incapable of providing informed consent.
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
Incidence and Causes of Erythrocytosis
Time frame: 5 years
The study will measure the incidence of primary and secondary causes of erythrocytosis, including polycythemia vera (PV), chronic hypoxia, medication use (e.g., SGLT2 inhibitors, testosterone), and other secondary causes. Data will be derived from clinical records and diagnostic investigations conducted as part of routine care. Unit of Measure: Proportion of participants (%) and count (n) categorized by cause over the study duration.
Diagnostic Accuracy of the JAKPOT Prediction Rule
Time frame: 5 years
The diagnostic accuracy of the JAKPOT prediction rule will be assessed for differentiating JAK2-positive erythrocytosis/PV from other causes. Measures will include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Unit of Measure: Sensitivity (%), specificity (%), PPV (%), and NPV (%).
5 secondary outcomes
Frequency of Management Strategies
Time frame: 5 years
Incidence of Thrombotic Events
Time frame: 5 years
Incidence of Bleeding Events
Time frame: 5 years
Disease Progression
Time frame: 5 years
Mortality
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Erythrocytosis and Polycythemia, run by Cyrus Hsia at 1 site in Canada.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 21 Jan 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyrus C. Hsia, MD, FRCPC (1-519-685-8500 ext. 56060, cyrus.hsia@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Causes of Erythrocytosis (time frame: 5 years). 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?
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 21 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.