UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021946 |
|---|---|
| Receipt number | R000025310 |
| Scientific Title | A nationwide survey of clinical outcome of patients with primary myelofibrosis in Japan |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2016/04/17 12:10:32 |
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Basic information
Public title
A nationwide survey of clinical outcome of patients with primary myelofibrosis in Japan
Acronym
A nationwide survey of patients with primary myelofibrosis in Japan
Scientific Title
A nationwide survey of clinical outcome of patients with primary myelofibrosis in Japan
Scientific Title:Acronym
A nationwide survey of patients with primary myelofibrosis in Japan
Region
| Japan |
Condition
Condition
Primary myelofibrosis
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A nationwide survey is conducted to elucidate the clinical features, treatments, and prognosis of primary myelofibrosis patients in Japan
Basic objectives2
Others
Basic objectives -Others
Assessment of internationalprognostic models for Japanese patients with primary myelofibrosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival in patients with primary myelofibrosis in Japan
Key secondary outcomes
Assessment of internationalprognostic models for Japanese patients with primary myelofibrosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed as primary myelofibrosis
Key exclusion criteria
Reject for enrollment in the study by patients or their family members
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Akashi |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Medicine and Biosystemic Science
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5228
akashi@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuto Takenaka |
Organization
Kyushu University Hospital
Division name
Center for Cellular and Molecular Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5230
Homepage URL
takenaka@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
The Idiopathic Disorders of Hematopoietic Organs Research Committee of Japan
Institute
Department
Personal name
Funding Source
Organization
The Idiopathic Disorders of Hematopoietic Organs Research Committee of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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 | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaires are sent annually to about 500 hematology departments. Newly diagnosed PMF patients are enrolled in this study and are followed annually to collect the prognostic information.The number of enrolled patients per year was around 50.
Management information
Registered date
| 2016 | Year | 04 | Month | 17 | Day |
Last modified on
| 2016 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025310
