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临床试验/NCT03618485
NCT03618485进行中(未招募)不适用

Registry of Patients With Myeloproliferative Neoplasms (MPNs) in Taiwan -Taiwan MPN Working Group

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
500
试验地点
1
主要终点
Epidemiological data of MPNs in Taiwan

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Epidemiological data of MPNs in Taiwan

时间窗: 24 month

The prevalence of MPNs during the whole study period in Taiwan

次要结局

  • The frequencies of mutations of driver genes in Taiwanese patients with MPNs.(24 months)
  • Occurrence of vascular events(36 months)
  • Occurrence of secondary acute myeloid leukemia (sAML)(36 months)
  • Treatment required(36 months)
  • Change of symptoms from baseline using MPN-10 symptom assessment.(36 months)
  • Overall survival(36 months)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lee-Yung Shih

Clinical Professor

Chang Gung Memorial Hospital

研究点 (1)

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