UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044095 |
|---|---|
| Receipt number | R000050354 |
| Scientific Title | Detection of unshared-HLA restricted T lymphocytes in HLA mismatched hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2021/05/05 |
| Last modified on | 2021/05/02 16:04:03 |
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Basic information
Public title
Detection of unshared-HLA restricted T lymphocytes in HLA mismatched hematopoietic stem cell transplantation
Acronym
Detection of unshared-HLA restricted T lymphocytes
Scientific Title
Detection of unshared-HLA restricted T lymphocytes in HLA mismatched hematopoietic stem cell transplantation
Scientific Title:Acronym
Detection of unshared-HLA restricted T lymphocytes
Region
| Japan |
Condition
Condition
Patients with hematologic disorder who undergoing HLA mismatched hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To detect donor-derived T lymphocytes restricted patient's HLA, which is a proof of thymic function in human adults
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To detect T lymphocytes restricted to patient's or donor's unique HLA
Key secondary outcomes
identification of T cell subsets of the T cells
functional test of the T cells
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who received HLA mismatched hematopoietic stem cell transplantation (haploidentical, 2-HLA-haplotype-mismatched, spousal, cord blood, marrow bank)
Key exclusion criteria
N/A
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ikegame |
Organization
Hyogo College of Medicine
Division name
Hematology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo
TEL
+81798456886
kame@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ikegame |
Organization
Hyogo College of Medicine
Division name
Hematology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo
TEL
+81798456886
Homepage URL
kame@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Helth and Labour Science Research Grants for Clinical Cancer Research from the Ministry of Health, Labour and Welfare, Japan, Grants-in aid for Scientific Research (21K08408)
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
IRB, Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo
Tel
+81798456886
kame@hyo-med.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
| 2021 | Year | 05 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | 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
To detect patient's or donor's unique HLA-restricted T lymphocytes in patients' blood who underwent HLA mismatched hematopoietic stem cell transplantation using HLA-A*24:02 CMV-pp65341-349tetramer (Medical & Biological Laboratories, Nagoya)
Management information
Registered date
| 2021 | Year | 05 | Month | 02 | Day |
Last modified on
| 2021 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050354
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
