EVAluation of Erythrocytosis PRospEctive Cohort STudy

NCT06785870 | Not Yet Recruiting

• 1 other identifier: HSREB125939
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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). This longitudinal, prospective study will generate high quality data that can help inform the optimal approach to diagnosis and management in this patient population.

Conditions

Erythrocytosis; Polycythemia; Polycythemia Secondary; Polycythemia Vera; Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase; Polycythemia Vera (PV); Polycythemia; Familial; Polycythemia, Primary

Keywords

Prospective; Observational Study; Erythrocytosis; Polycythemia; Patient Registry; Diagnosis; Management; Outcomes

Outcome Measures

Primary Outcomes (2)

• 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.

  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 (%).

  5 years

Secondary Outcomes (5)

• Frequency of Management Strategies

  5 years

• Incidence of Thrombotic Events

  5 years

• Incidence of Bleeding Events

  5 years

• Disease Progression

  5 years

• Mortality

  5 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients \<18 years.
• Patients without erythrocytosis.
• Patients incapable of providing informed consent.

Sponsors & Collaborators

• Cyrus Hsia: lead

Study Sites (1)

Victoria Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Polycythemia; Polycythemia Vera; Polycythemia, primary familial and congenital; Disease

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Myeloproliferative Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cyrus C. Hsia, MD, FRCPC

CONTACT

1-519-685-8500; cyrus.hsia@lhsc.on.ca

Benjamin Chin-Yee, MD, FRCPC

CONTACT

1-519-685-8718; benjamin.chin-yee@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hematologist

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: January 21, 2025
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 21, 2025

Record last verified: 2025-01

Locations

CA (1)