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.
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.
Patients <18 years.
Patients without erythrocytosis.
Patients incapable of providing informed consent.
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.
Cohort
Prospective
Not listed
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.
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 (%).
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
Cyrus Hsia
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
