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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024340
Receipt No. R000027330
Scientific Title Prospective observational study to assess the prognosis of patients with myeloproliferative neoplasms in Japan
Date of disclosure of the study information 2016/10/13
Last modified on 2017/05/10

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Basic information
Public title Prospective observational study to assess the prognosis of patients with myeloproliferative neoplasms in Japan
Acronym JSH-MPN-15
Scientific Title Prospective observational study to assess the prognosis of patients with myeloproliferative neoplasms in Japan
Scientific Title:Acronym 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
1st name
Middle name
Last name Norio Komatsu
Organization Juntendo University medicine graduate course
Division name Hematology
Zip code
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
1st name
Middle name
Last name Katsuto Takenaka
Organization Kyushu University Hospital
Division name Hematology and Oncology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 05 Month 16 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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