Essential Thrombocythemia, Myeloproliferative Neoplasm, Polycythemia Vera, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Primary Myelofibrosis, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage
Conditions
Keywords
Myeloproliferative neoplasm, Epidemiology, Outcome, Prognostic factors
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.
Interventions
None listed
Sponsors
Novartis
The University of Hong Kong
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old at the time of diagnosis of MPN. 2. 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): 1. Polycythaemia vera 2. Essential thrombocythemia 3. Primary myelofibrosis, pre-fibrotic/early stage 4. Primary myelofibrosis, overt fibrotic stage 5. Post-polycythaemia vera myelofibrosis 6. Post-essential thrombocythaemia myelofibrosis 7. MPN-unclassifiable 3. All subjects need to provide informed consent.
Exclusion criteria
A subject will not be eligible if he/she meets any of the following criteria: 1\. Subject was diagnosed with myelodysplastic syndrome, myelodysplastic syndrome/myeloproliferative neoplasm, or chronic myeloid leukaemia BCR-ABL1 positive, under the 2017 WHO classification
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hong Kong
Contacts
Primary ContactHarinder Gill, MD
Outcome results
None listed