Asian Myeloproliferative Neoplasm (MPN) Registry

Sponsor

The University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT05882773

Collaborator

Novartis (Industry)

1,000

Enrollment

Location

Anticipated Duration (Months)

23.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myeloproliferative Neoplasm Polycythemia Vera Essential Thrombocythemia Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis Primary Myelofibrosis Primary Myelofibrosis, Prefibrotic Stage Primary Myelofibrosis, Fibrotic Stage

Detailed Description

This is a multinational, multicenter, prospective and retrospective, observational, cohort registry of patients with MPN. The registry mainly involves study centres in Asia including but not limited to Hong Kong, Singapore, Malaysia, Taiwan, Korea and Thailand. Clinicopathologic characteristics, cytogenetic characteristics, mutational characteristics, treatment characteristics, outcomes and survivals of Asian patients MPN diagnosed between 2010-2025 will be collected to establish clinical registry.

Data on the clinicopathologic characteristics, cytogenetics, mutational profile, prognostic scoring treatment characteristics, responses to treatment, outcome and survivals will be collected through routine clinic visits and/or reviewing medical records. Data will be collected at diagnosis, and approximately every 6 months thereafter (for prospective data) and at progression until death/study termination.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Asian Myeloproliferative Neoplasm (MPN) Registry - An Asian Myeloid Working Group (AMWG) Project.

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Outcome Measures

Primary Outcome Measures

Time to progression to secondary myelofibrosis (for PV and ET) [10 years]
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
Progression-free survival (PFS) [10 years]
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.
Overall survival (OS) [10 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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