Registry of Patients With MPNs in Taiwan

NCT03618485 | Active Not Recruiting

• 1 other identifier: 201700356B0
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myeloproliferative Neoplasms

Outcome Measures

Primary Outcomes (1)

• Epidemiological data of MPNs in Taiwan

  The prevalence of MPNs during the whole study period in Taiwan

  24 month

Secondary Outcomes (6)

• The frequencies of mutations of driver genes in Taiwanese patients with MPNs.

  24 months

• Treatment required

  36 months

• Change of symptoms from baseline using MPN-10 symptom assessment.

  36 months

• Occurrence of vascular events

  36 months

• Occurrence of secondary acute myeloid leukemia (sAML)

  36 months

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital-Linkou

Taoyuan District, State, 33305, Taiwan

Location

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 7, 2018
• Study Start: April 1, 2017
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

TW (1)