Asian Myeloproliferative Neoplasm (MPN) Registry

NCT05882773 | Recruiting DMC

• 1 other identifier: AMWG002
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multinational, multicenter, prospective and retrospective, observational, cohort study of patients with myeloproliferative neoplasm.

Conditions

Myeloproliferative Neoplasm; Polycythemia Vera; Essential Thrombocythemia; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis; Primary Myelofibrosis; Primary Myelofibrosis, Prefibrotic Stage; Primary Myelofibrosis, Fibrotic Stage

Keywords

Myeloproliferative neoplasm; Epidemiology; Outcome; Prognostic factors

Outcome Measures

Primary Outcomes (3)

• Time to progression to secondary myelofibrosis (for PV and ET)

  Measured in months, from date of diagnosis of MPN to date of documentation of secondary myelofibrosis (event), death (event) or latest follow-up (censor). Patient without an event will be censored at date last known to be progression-free

  10 years

• Progression-free survival (PFS)

  Measured in months, from date of diagnosis of MPN to the date of the first MDS or AML or death due to any cause. Patient without an event will be censored at date last known to be progression-free and alive.

  10 years

• Overall survival (OS)

  Measured in months from the date of diagnosis of MDS until the date of death due to any cause. Patient who is alive will be censored at the date last known alive

  10 years

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

Three study cohorts will be involved in the study. They are: Prospective cohort - Subjects will be enrolled in the study at their diagnosis of MPN. All data will be collected on-study prospectively. Partial prospective/retrospective cohort (partial-P/R) - Subjects will be enrolled in the study after they have been diagnosed of MPN for a period of time and still being followed up clinically (alive). Data from study enrollment forward will be collected prospectively at around 6-month intervals on-study. Data prior to study enrollment are the events of interest happened and will be collected retrospectively. Retrospective cohort - Subjects enrolled in the study after they were diagnosed of MPN and died/lost to follow. All data will be collected retrospectively.

You may qualify if:

• Age ≥ 18 years old at the time of diagnosis of MPN.
• Subject was diagnosed with one of the following disorders according to the 2017 WHO classification (for patients diagnosed before 2017, the bone marrow reports will be re-evaluated according to the 2017 WHO classification):
• Polycythaemia vera
• Essential thrombocythemia
• Primary myelofibrosis, pre-fibrotic/early stage
• Primary myelofibrosis, overt fibrotic stage
• Post-polycythaemia vera myelofibrosis
• Post-essential thrombocythaemia myelofibrosis
• MPN-unclassifiable
• All subjects need to provide informed consent.

You may not qualify if:

• A subject will not be eligible if he/she meets any of the following criteria:
• \. Subject was diagnosed with myelodysplastic syndrome, myelodysplastic syndrome/myeloproliferative neoplasm, or chronic myeloid leukaemia BCR-ABL1 positive, under the 2017 WHO classification

Sponsors & Collaborators

• The University of Hong Kong: lead
• Novartis: collaborator

Study Sites (1)

Department of Medicine, Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and bone marrow aspirate

MeSH Terms

Conditions

Myeloproliferative Disorders; Polycythemia Vera; Thrombocythemia, Essential; Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders

Study Officials

• Harinder Gill, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harinder Gill, MD

CONTACT

+852 22554542; gillhsh@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: May 31, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

HK (1)