Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03618485
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-31
First Post:
2018-07-16
Brief Title:
Registry of Patients With MPNs in Taiwan
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Registry of Patients With Myeloproliferative Neoplasms MPNs in Taiwan -Taiwan MPN Working Group
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 prefibroticearly 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
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 prefibroticearly 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None