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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044095
Receipt No. 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

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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
Email 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
Email kame@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050354

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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