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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005212
Receipt No. R000006193
Scientific Title Observational study of unrelated peripheral blood stem cell transplantation in Japan
Date of disclosure of the study information 2011/03/08
Last modified on 2017/03/12

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Basic information
Public title Observational study of unrelated peripheral blood stem cell transplantation in Japan
Acronym Observational study of URPBSCT
Scientific Title Observational study of unrelated peripheral blood stem cell transplantation in Japan
Scientific Title:Acronym Observational study of URPBSCT
Region
Japan

Condition
Condition Hematological malignant and benaign disease which are approved by Japanese Bone Marrow Program (JMDP)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Operation of observational Study of the results of unrelated peripheral blood stem cell transplantation which has just started in Japan
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival 100 days after transplantation for hematological malignant disease
Key secondary outcomes

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
0 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patients who meet the criteria of JMDP (hematological malignant and benign disease) and who receive unrelated peripheral blood stem cell transplantation from a HLA-A, B, C, DRB1 genotypically identical donor who is coordinated by JMDP.
Key exclusion criteria All patients who does not meet the key inclusion criteria
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Miyamura
Organization Japanese Red Cross Nagoya First Hospital
Division name Department of Hematology
Zip code
Address 3-35, Michishita-cho, Nakamura-ku, Nagoya
TEL 052-481-5111
Email miyamu@nagoya-1st.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Juinji Tanaka
Organization Hokkaido University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address Sapporo Hokkaido
TEL 011-706-7214
Homepage URL
Email jutanaka@med.hokudai.ac.jp

Sponsor
Institute MHLW supporting study group:Study for medical practice, medical science and social basis for allogeneic unrelated peripheral blood stem cell transplantation
Institute
Department

Funding Source
Organization MHLW supporting study group:Study for medical practice, medical science and social basis for allogeneic unrelated peripheral blood stem cell transplantation
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
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
2011 Year 03 Month 08 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 Day 100 survival is the same of that in unrelated bone marrow transplantaion.
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 No longer recruiting
Date of protocol fixation
2011 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information The data which are registrated into JSHCT data center and additional data of chronic GVHD are collected 100, 6 months and 1 year after transplantaion

Management information
Registered date
2011 Year 03 Month 08 Day
Last modified on
2017 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006193

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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