UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046860 |
|---|---|
| Receipt number | R000053463 |
| Scientific Title | Clinical study of a diagnostic technology using a novel T-cell function assay for graft-versus-host disease (GVHD) after allogenic hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2022/02/10 |
| Last modified on | 2023/08/08 09:04:42 |
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Basic information
Public title
Clinical study of a novel T-cell function assay for graft-versus-host disease (GVHD) after allogenic hematopoietic stem cell transplantation
Acronym
Clinical study of a novel T-cell function assay for graft-versus-host disease (GVHD) after allogenic hematopoietic stem cell transplantation
Scientific Title
Clinical study of a diagnostic technology using a novel T-cell function assay for graft-versus-host disease (GVHD) after allogenic hematopoietic stem cell transplantation
Scientific Title:Acronym
Clinical study of a novel T-cell function assay for graft-versus-host disease (GVHD) after allogenic hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
Hematologic Malignancies, Aplastic Anemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the stimulus-responsive T cell rate in GVHD after hematopoietic stem cell transplantation
Basic objectives2
Others
Basic objectives -Others
Clinical utility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the stimulus-responsive T cells
Key secondary outcomes
Severity of GVHD
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients with hematopoietic tumor or aplastic anemia to plan allogeneic hematopoietic stem cell transplantation
Key exclusion criteria
Adults who are deemed unlikely to provide valid consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | YASUI |
Organization
The University of Tokyo
Division name
The Institute of Medical Science
Zip code
108-8639
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo, JAPAN
TEL
0334438111
hiroyasu@ims.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | YASUI |
Organization
The University of Tokyo
Division name
The Institute of Medical Science
Zip code
108-8639
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo, JAPAN
TEL
0334438111
Homepage URL
hiroyasu@ims.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Sysmex Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, The Institute of Medical Science, The University of Tokyo
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo, JAPAN
Tel
03-6409-2035
NA
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
都立駒込病院血液内科（東京都）
日本赤十字医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study to evaluate clinical usefulness of a diagnostic technique using a novel T-cell function assay for graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation
Management information
Registered date
| 2022 | Year | 02 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053463
