Myeloproliferative NeoplasmNCT05882773
Asian Myeloproliferative Neoplasm (MPN) Registry
An observational study of Myeloproliferative Neoplasm and Polycythemia Vera, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a multinational, multicenter, prospective and retrospective, observational, cohort study of patients with myeloproliferative neoplasm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm, Polycythemia Vera, Essential Thrombocythemia
- How many people
- 1,000 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2023to Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Three study cohorts will be involved in the study. They are: Prospective cohort - Subjects will be enrolled in the study at their diagnosis of MPN. All data will be collected on-study prospectively. Partial prospective/retrospective cohort (partial-P/R) - Subjects will be enrolled in the study after they have been diagnosed of MPN for a period of time and still being followed up clinically (alive). Data from study enrollment forward will be collected prospectively at around 6-month intervals on-study. Data prior to study enrollment are the events of interest happened and will be collected retrospectively. Retrospective cohort - Subjects enrolled in the study after they were diagnosed of MPN and died/lost to follow. All data will be collected retrospectively.
Who may be able to join
- 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
Show all 10Show fewer
- Post-polycythaemia vera myelofibrosis
- Post-essential thrombocythaemia myelofibrosis
- MPN-unclassifiable
- All subjects need to provide informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Medicine, Queen Mary Hospital
Hong Kong
Harinder Gill, MD, +852 22554542, gillhsh@hku.hk
Harinder Gill, MD
About this study
Official title: Asian Myeloproliferative Neoplasm (MPN) Registry - An Asian Myeloid Working Group (AMWG) Project.
This is a multinational, multicenter, prospective and retrospective, observational, cohort study of patients with myeloproliferative neoplasm.
Read the 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.
- Conditions
- Myeloproliferative Neoplasm, Polycythemia Vera, Essential Thrombocythemia, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Primary Myelofibrosis
- Keywords
- Myeloproliferative neoplasm, Epidemiology, Outcome, Prognostic factors
- Medical subject headings
- Myeloproliferative Disorders, Polycythemia Vera, Thrombocythemia, Essential, Primary Myelofibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression to secondary myelofibrosis (for PV and ET)
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
Measured: 10 years
Progression-free survival (PFS)
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.
Measured: 10 years
Overall survival (OS)
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Harinder Gill, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882773
- Sponsor's protocol ID
- AMWG002
- Status last verified
- May 2023
- First submitted
- 21 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian Myeloproliferative Neoplasm (MPN) Registry - An Asian Myeloid Working Group (AMWG) Project.
- ClinicalTrials.gov ID
- NCT05882773
- Acronym / sponsor ID
- AMWG002
- Conditions
- Myeloproliferative Neoplasm, Polycythemia Vera, Essential Thrombocythemia, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Primary Myelofibrosis
- Keywords
- Myeloproliferative neoplasm, Epidemiology, Outcome, Prognostic factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- May 2023 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three study cohorts will be involved in the study. They are: Prospective cohort - Subjects will be enrolled in the study at their diagnosis of MPN. All data will be collected on-study prospectively. Partial prospective/retrospective cohort (partial-P/R) - Subjects will be enrolled in the study after they have been diagnosed of MPN for a period of time and still being followed up clinically (alive). Data from study enrollment forward will be collected prospectively at around 6-month intervals on-study. Data prior to study enrollment are the events of interest happened and will be collected retrospectively. Retrospective cohort - Subjects enrolled in the study after they were diagnosed of MPN and died/lost to follow. All data will be collected retrospectively.
Key inclusion criteria (10 listed)
- 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):
- All subjects need to provide informed consent.
Key exclusion criteria (2 listed)
- 1. Subject was diagnosed with myelodysplastic syndrome, myelodysplastic syndrome/myeloproliferative neoplasm, or chronic myeloid leukaemia BCR-ABL1 positive, under the 2017 WHO classification
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harinder Gill, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm and Polycythemia Vera, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harinder Gill, MD (+852 22554542, gillhsh@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression to secondary myelofibrosis (for PV and ET) (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.