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NCT Number: NCT05882773

Asian Myeloproliferative Neoplasm (MPN) Registry

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Harinder Gill, MD

CONTACT

[email protected]

+852 22554542

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 31, 2023
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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