UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033911 |
|---|---|
| Receipt number | R000037635 |
| Scientific Title | Analysis of allogenic stem cell transplantation for primary immunodeficiency using TRUMP data |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2022/01/19 11:58:53 |
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Basic information
Public title
Analysis of allogenic stem cell transplantation for primary immunodeficiency using TRUMP data
Acronym
Analysis of allo-HCT for PIDs in Japan
Scientific Title
Analysis of allogenic stem cell transplantation for primary immunodeficiency using TRUMP data
Scientific Title:Acronym
Analysis of allo-HCT for PIDs in Japan
Region
| Japan |
Condition
Condition
Primary immunodeficiency
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In order to improve hematopoietic cell transplantation (HCT) for primary immunodeficiencies (PIDs), we clarify the significance, efficacy and the risks of HCT, optimal donor selection, the choice of conditioning regimens, and management guidelines for adverse events by analyzing the data of patients with PIDs who have received HCT in Japan using PIDJ and TRUMP data.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival/ event-free survival in patients with PID after HCT
Key secondary outcomes
We divide the patients into following subgroups; different periods of years, disease categories according to International Union of Immunological Societies; IUIS classification, pre-HCT status of complications; infection, autoimmune disease or autoinflammatory diseases, conditioning regimen; myeloablative, reduced intensity or nothing, and donor sources. We analyze survival, adverse events and long-term immunological reconstitution (i.e. post-transplant chimerism and secession of immunoglobulin supplementation) in each subgroup.
In addition, we identify the factors contributing to survival by multivariate analysis, as well as the risks for post-HCT adverse events such as graft-versus host disease, infection or the late complications.
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
The patients with PID in TRUMP registration who have received HCT from January 1974 to December 2016
Key exclusion criteria
The patients whose TRUMP data are insufficient for analysis.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Morio |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Pediatrics and Developmental Biology
Zip code
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5249
tmorio.ped@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Miyamoto |
Organization
Tokyo Medical and Dental University
Division name
Department of Pediatrics
Zip code
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5249
Homepage URL
smiyped@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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
| 2018 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2018 | Year | 08 | Month | 27 | Day |
Last modified on
| 2022 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037635
