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Asian Myeloproliferative Neoplasm (MPN) Registry

NCT ID: NCT05882773

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-31

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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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

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Myeloproliferative neoplasm Epidemiology Outcome Prognostic factors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harinder Gill, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Department of Medicine, Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Harinder Gill, MD

Role: CONTACT

Phone: +852 22554542

Email: [email protected]

Facility Contacts

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Harinder Gill, MD

Role: primary

Other Identifiers

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AMWG002

Identifier Type: -

Identifier Source: org_study_id