UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030256
Receipt number 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 11:13:47

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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 or person

Institute

Center for Advanced Medicine and Clinical Research, Nagoya University Hospital

Institute

Department

Personal name



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

Value
https://center6.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