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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030256
Receipt No. R000034542
Scientific Title Optimization of the number of donors in JMDP and preserved cord blood units in cord blood banks
Date of disclosure of the study information 2017/12/11
Last modified on 2020/03/03

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Basic information
Public title Optimization of the number of donors in JMDP and preserved cord blood units in cord blood banks
Acronym Optimization of the donor pools
Scientific Title Optimization of the number of donors in JMDP and preserved cord blood units in cord blood banks
Scientific Title:Acronym Optimization of the donor pools
Region
Japan

Condition
Condition Hematological disorders, solid tumors
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the optimal donor pools by analyzing relationship between the numbers of registered donors and preserved cord blood units and the number of performed allogneic hematopoietic cell transplantation
Basic objectives2 Others
Basic objectives -Others donor size
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The optimal size of registered donors and preserved cord blood units
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent allogeneic hematopoietic cell transplantation in Japan between 1998 and 2013 and whose data were registered in the TRUMP database
Key exclusion criteria Patients who refused the use of their data
Target sample size 42000

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Nishiwaki
Organization Nagoya University Hospital
Division name Center for Advanced Medicine and Clinical Research
Zip code 466-8560
Address 65 Tsurumai-cho Showa-ku Nagoya 4668560, Japan
TEL +81-52-744-2942
Email n-3104@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Nishiwaki
Organization Nagoya University Hospital
Division name Center for Advanced Medicine and Clinical Research
Zip code 466-8560
Address 65 Tsurumai-cho Showa-ku Nagoya 4668560, Japan
TEL +81-52-744-2942
Homepage URL
Email n-3104@med.nagoya-u.ac.jp

Sponsor
Institute Center for Advanced Medicine and Clinical Research, Nagoya University Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagoya University
Address 65 Tsurumai-cho Showa-ku, Nagoya
Tel 052-744-2973
Email ethics@med.nagoya-u.ac.jp

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
2017 Year 12 Month 11 Day

Related information
URL releasing protocol None
Publication of results Published

Result
URL related to results and publications https://www.nature.com/articles/s41409-019-0542-0
Number of participants that the trial has enrolled 30465
Results For donor registrants, the optimal numbers in 2008 and 2013 from the formulas 2004-2008 and 2009-2013 were 467000 and 561000, respectively, whereas the actual numbers were 314468 and 433703, respectively. For UCB units, the estimated numbers in 2008 and 2013 from the formulas 2004-2008 and 2009-2013 were 7090 and 17000 , respectively, whereas the actual numbers were 3253 and 6946, respectively.
Results date posted
2020 Year 03 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics This study included all patients who underwent allogeneic hematopoietic cell transplantation between 2004 and 2013.
Clinical data were obtaind from the Transplant Registry Unified Management Program database of the Japan Society for Hematopoietic Cell Transplantation. Donor-recipient HLA matching data of unrelated bone marrow/peripheral blood stem cell transplantation, number of donor registrants, and unrelated donor coordination period were obtained from the Japan Marrow Donor Program, and data of registered UCB units were obtained from the Japanese Red Cross Society.
Participant flow NA
Adverse events NA
Outcome measures To estimate the optimal number of unrelated donor registrants and registered unrelated cord blood units.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 12 Month 11 Day
Date of IRB
2017 Year 07 Month 25 Day
Anticipated trial start date
2017 Year 12 Month 11 Day
Last follow-up date
2017 Year 12 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 03 Day

Other
Other related information Retrospective analyses using TRUMP database

Management information
Registered date
2017 Year 12 Month 04 Day
Last modified on
2020 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034542

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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