Myeloproliferative NeoplasmsNCT03618485
Registry of Patients With MPNs in Taiwan
An observational study of Myeloproliferative Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Myeloproliferative neoplasms (MPNs) are a group of clonal hematologic malignancies with great variation in reported patient life expectancy and are characterized by a relatively indolent course which can be complicated by thromboembolic events and transformation to acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myeloproliferative Neoplasms
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2017to 31 Dec 2025
- How long will I take part?
- 6 Months
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with MPNs newly diagnosed and followed in Chang Gung Memorial Hospital and cooperative hospitals.Registry will be limited to patients newly diagnosed between 2016 and 2019. Newly diagnosed means having the first bone marrow biopsy within 12 months from diagnosis.
Who may be able to join
- Male and female patients aged ≥ 20 years.
- Patient who had a confirmed diagnosis according to the 2016 revised WHO criteria with a Ph (-) MPN.
Who cannot join
- Patients do not fulfill the diagnostic criteria of MPN by WHO 2016 classification.
- Patients unwilling to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registry of Patients With Myeloproliferative Neoplasms (MPNs) in Taiwan -Taiwan MPN Working Group
Myeloproliferative neoplasms (MPNs) are a group of clonal hematologic malignancies with great variation in reported patient life expectancy and are characterized by a relatively indolent course which can be complicated by thromboembolic events and transformation to acute myeloid leukemia (AML).
The MPNs in the 2016 World Health Organization (WHO) classification of myeloid neoplasms consist of polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) including prefibrotic/early stage and over fibrotic stage, chronic myeloid leukemia, other (rare) disorders such as chronic neutrophilic leukemia and chronic eosinophilic leukemia and MPN unclassifiable (MPN-U).
Read more
The prevalence and genetic characteristics of patients with MPNs in Taiwan are still unknown. Molecular tests which are required for the diagnosis of MPNs are not available in many hospitals which hamper the accurate diagnosis and subtype classification of MPNs. Moreover, the information of current therapeutic strategy for MPNs in most medical centers in Taiwan is also not available. The purpose of this MPN registry is to collect clinical data, molecular characteristics, treatment details and response to therapy, occurrence of complications during the course, disease progression to secondary myelofibrosis from PV or ET and secondary AML (sAML) transformation as well as survival. The clinical and molecular data including the high molecular risk (HMR) genes will be examined and correlated with treatment outcomes in Taiwanese MPN patients.
The Molecular Diagnostic Laboratory at Chang Gung Memorial Hospital-Linkou is a College of American Pathologists (CAP)-accredited lab which provides high quality of molecular genetic tests for hematologic malignancies. The three driver gene mutations are the major criteria for the diagnosis of MPN, the methodologies of mutational analyses have been well set up for the clinical use in this lab. In addition, this lab is also equipped with facilities for the detection of mutated genes which were recently identified as HRM category (presence of any of ASXL1, EZH2, SRSF2, IDH1 or IDH2), and mutations of other epigenetic regulators or splicing factors.
- Conditions
- Myeloproliferative Neoplasms
- Medical subject headings
- Myeloproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological data of MPNs in Taiwan
The prevalence of MPNs during the whole study period in Taiwan
Measured: 24 month
Secondary outcomes (6)
The frequencies of mutations of driver genes in Taiwanese patients with MPNs.
The frequencies of JAK2V617F or JAK exon12, CALR and MPL in each subtype of patient's with MPN during the two years of study period.
Measured: 24 months
Treatment required
Date of phlebotomy and date of initiation of drug therapy
Measured: 36 months
Change of symptoms from baseline using MPN-10 symptom assessment.
Change of symptoms from baseline in MPN-10 at different time points (V2-5) during the study period.
Measured: 36 months
Occurrence of vascular events
Date of occurrence of thrombosis or bleeding during the study period.
Measured: 36 months
Occurrence of secondary acute myeloid leukemia (sAML)
Date of the development of sAML
Measured: 36 months
Overall survival
Time from diagnosis of MPN to last follow-up or date of death measured by months
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Apr 2017
- Primary completion31 Jul 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee-Yung Shih, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618485
- Sponsor's protocol ID
- 201700356B0
- Status last verified
- Feb 2025
- First submitted
- 16 Jul 2018
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Patients With Myeloproliferative Neoplasms (MPNs) in Taiwan -Taiwan MPN Working Group
- ClinicalTrials.gov ID
- NCT03618485
- Acronym / sponsor ID
- 201700356B0
- Conditions
- Myeloproliferative Neoplasms
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Aug 2018 (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.
Myeloproliferative neoplasms (MPNs) are a group of clonal hematologic malignancies with great variation in reported patient life expectancy and are characterized by a relatively indolent course which can be complicated by thromboembolic events and transformation to acute myeloid leukemia (AML).
The MPNs in the 2016 World Health Organization (WHO) classification of myeloid neoplasms consist of polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) including prefibrotic/early stage and over fibrotic stage, chronic myeloid leukemia, other (rare) disorders such as chronic neutrophilic leukemia and chronic eosinophilic leukemia and MPN unclassifiable (MPN-U).
The prevalence and genetic characteristics of patients with MPNs in Taiwan are still unknown. Molecular tests which are required for the diagnosis of MPNs are not available in many hospitals which hamper the accurate diagnosis and subtype classification of MPNs. Moreover, the information of current therapeutic strategy for MPNs in most medical centers in Taiwan is also not available. The purpose of this MPN registry is to collect clinical data, molecular characteristics, treatment details and response to therapy, occurrence of complications during the course, disease progression to secondary myelofibrosis from PV or ET and secondary AML (sAML) transformation as well as survival. The clinical and molecular data including the high molecular risk (HMR) genes will be examined and correlated with treatment outcomes in Taiwanese MPN patients.
The Molecular Diagnostic Laboratory at Chang Gung Memorial Hospital-Linkou is a College of American Pathologists (CAP)-accredited lab which provides high quality of molecular genetic tests for hematologic malignancies. The three driver gene mutations are the major criteria for the diagnosis of MPN, the methodologies of mutational analyses have been well set up for the clinical use in this lab. In addition, this lab is also equipped with facilities for the detection of mutated genes which were recently identified as HRM category (presence of any of ASXL1, EZH2, SRSF2, IDH1 or IDH2), and mutations of other epigenetic regulators or splicing factors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with MPNs newly diagnosed and followed in Chang Gung Memorial Hospital and cooperative hospitals.Registry will be limited to patients newly diagnosed between 2016 and 2019. Newly diagnosed means having the first bone marrow biopsy within 12 months from diagnosis.
Key inclusion criteria (2 listed)
- Male and female patients aged ≥ 20 years.
- Patient who had a confirmed diagnosis according to the 2016 revised WHO criteria with a Ph (-) MPN.
Key exclusion criteria (2 listed)
- Patients do not fulfill the diagnostic criteria of MPN by WHO 2016 classification.
- Patients unwilling to sign informed consent.
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
Epidemiological data of MPNs in Taiwan
Time frame: 24 month
The prevalence of MPNs during the whole study period in Taiwan
6 secondary outcomes
The frequencies of mutations of driver genes in Taiwanese patients with MPNs.
Time frame: 24 months
Treatment required
Time frame: 36 months
Change of symptoms from baseline using MPN-10 symptom assessment.
Time frame: 36 months
Occurrence of vascular events
Time frame: 36 months
Occurrence of secondary acute myeloid leukemia (sAML)
Time frame: 36 months
Overall survival
Time frame: 36 months
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 14 Feb 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 14 Feb 2025. 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological data of MPNs in Taiwan (time frame: 24 month). 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 14 Feb 2025.