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Active, not recruitingNCT03618485Updated Feb 14, 2025

Registry of Patients With MPNs in Taiwan

An observational study in Myeloproliferative Neoplasms, sponsored by Chang Gung Memorial Hospital. Active, not recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by Chang Gung Memorial Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Ages
20 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Myeloproliferative Neoplasms
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In context

Myeloproliferative Disorders

640 studies on the registry are indexed under Myeloproliferative Disorders; 111 are open to participants now.

This study's enrollment of 500 is above the median of 143 across 113 observational studies indexed under Myeloproliferative Disorders.

Browse Myeloproliferative Disorders studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 238 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female patients aged ≥ 20 years.
  2. Patient who had a confirmed diagnosis according to the 2016 revised WHO criteria with a Ph (-) MPN.

Exclusion criteria

Exclusion Criteria:

  1. Patients do not fulfill the diagnostic criteria of MPN by WHO 2016 classification.
  2. Patients unwilling to sign informed consent.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Epidemiological data of MPNs in Taiwan

    The prevalence of MPNs during the whole study period in Taiwan

    Time frame: 24 month

Secondary outcomes

  1. 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.

    Time frame: 24 months

  2. Treatment required

    Date of phlebotomy and date of initiation of drug therapy

    Time frame: 36 months

  3. 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.

    Time frame: 36 months

  4. Occurrence of vascular events

    Date of occurrence of thrombosis or bleeding during the study period.

    Time frame: 36 months

  5. Occurrence of secondary acute myeloid leukemia (sAML)

    Date of the development of sAML

    Time frame: 36 months

  6. Overall survival

    Time from diagnosis of MPN to last follow-up or date of death measured by months

    Time frame: 36 months

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Study locations

1 site
  • Chang Gung Memorial Hospital-Linkou
    Taoyuan, State 33305, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03618485
Responsible party
Lee-Yung Shih (Clinical Professor, Chang Gung Memorial Hospital) — Principal investigator
First posted
Aug 7, 2018
Start date
Apr 1, 2017
Primary completion
Jul 31, 2023
Completion
Dec 31, 2025 (estimated)
Last update
Feb 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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