Asian Myeloproliferative Neoplasm (MPN) Registry - An Asian Myeloid Working Group (AMWG) Project.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Time to progression to secondary myelofibrosis (for PV and ET)
Study Overview
Brief Summary
This is a multinational, multicenter, prospective and retrospective, observational, cohort study of patients with myeloproliferative neoplasm.
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
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Time to progression to secondary myelofibrosis (for PV and ET)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported