UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024340 |
|---|---|
| Receipt number | 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 10:50:01 |
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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
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
takenaka@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
THE JAPANESE SOCIETY OF HEMATOLOGY
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027330
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
