An observational study in Erythrocytosis, Polycythemia and Polycythemia Secondary, sponsored by Cyrus Hsia. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-21.
Sponsored by Cyrus Hsia · Observational
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.
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:
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.
32 studies on the registry are indexed under Polycythemia; 12 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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 (%).
Time frame: 5 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Plan to share: Undecided
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