UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study to assess the prognosis of patients with myeloproliferative neoplasms in Japan
Title of the study (Brief title)	JSH-MPN-15
Region	Japan

Condition
Condition	MPN(myeloproliferative neoplasms)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The objectives of this study are to assess overall survival, event rates, risk factors associated with events, and applied treatment modalities in polycythemia vera, essential thrombocythemia, prefibrotic primary myelofibrosis and primary myelofibrosis in Japan.
Basic objectives2	Others
Basic objectives -Others	Epidemiology
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Investigation of overall survival of MPN (PV,ET,prePMF,PMF) patients in Japan.
Key secondary outcomes	Investigation of thrombotic and hemorrhagic events, transition rates and associated risk factors of transition to leukemia, secondary myelofibrosis and polycythemia vera -thrombotic and hemorrhagic events -transition to leukemia -transition to secondary myelofibrosis -transition to polycythemia vera -secondary malignancies -MPN-SAF TSS (Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients fulfilling the following criteria (1) Newly diagnosed patients fulfilling the 2016 WHO diagnostic criteria for MPN (2) Patients who have undergone a bone marrow biopsy with a presentable pathology report (3) Confirmed absence of either the Ph1 chromosome or BCR-ABL fusion gene (4) Patients in which informed consent was obtainable (5) Patients who were 16 years or older at the time of consent
Key exclusion criteria	Patients in which exclusion of MDS was not possible due to confirmation of myeloid or erythroid lineage morphological abnormalities on the bone marrow smear preparation
Target sample size	1500

Research contact person
Name of lead principal investigator	Norio Komatsu
Organization	Juntendo University medicine graduate course
Division name	Hematology
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL	03-5802-1069
Email	komatsun@juntendo.ac.jp

Public contact
Name of contact person	Katsuto Takenaka
Organization	Kyushu University Hospital
Division name	Hematology and Oncology
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL	092-641-1151
Homepage URL
Email	takenaka@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute	THE JAPANESE SOCIETY OF HEMATOLOGY
Institute
Department

Funding Source
Organization	Japanese Society of Hematology(JSH)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 13 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 16 Day
Anticipated trial start date	2016 Year 10 Month 18 Day
Last follow-up date	2031 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design: Multicenter prospective observational study Patients' recruit: All patients fulfilling the inclusion criteria at the participating institutes between April 2016 and March 2021.

Management information
Registered date	2016 Year 10 Month 08 Day
Last modified on	2017 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027330