UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039682 |
|---|---|
| Receipt number | R000045182 |
| Scientific Title | Development of novel allo- or tumor-reactive T cell analyzing assay and exploring novel approach to manipulate T cell response |
| Date of disclosure of the study information | 2020/03/04 |
| Last modified on | 2020/03/03 23:14:18 |
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Basic information
Public title
Study for regulating reactive T cells against allograft and tumor
Acronym
Study for regulating reactive T cells against allograft and tumor
Scientific Title
Development of novel allo- or tumor-reactive T cell analyzing assay and exploring novel approach to manipulate T cell response
Scientific Title:Acronym
Development of novel allo- or tumor-reactive T cell analyzing assay and exploring novel approach to manipulate T cell response
Region
| Japan |
Condition
Condition
Organ transplantation
Malignant tumor
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exploring and developing novel assay and analysis for T cell immunity for transplantation tolerance and tumor.
Basic objectives2
Others
Basic objectives -Others
Novel immune monitoring
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of antigen specific T cell in allo and tumor specific stimulation
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Available informed consent from identical person
Key exclusion criteria
1, The person with regular hospital visit
2, THe person who have a axiuos about thier health.
3, The person with weight less than 40kg.
4, the person who did blood donation within 1 month.
5, The person possibly be pregnant.
6, The person has a history of infectious disease within a week.
7, The person who has a direct interst with the investigators, like teacher and student.
8, The person who is recognized as inappropriate for the candidate by investigators.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ohdan |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Gastroenterological and Transplant Surgery
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5220
hohdan@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Tanimine |
Organization
Hiroshima University Hospital
Division name
Department of Gstroenterological and Transplant Surgery
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5220
Homepage URL
tanimine@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Department of Gstroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University
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
Department of Gstroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
Tel
082-257-5220
tanimine@hirsohima-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
| 2020 | Year | 03 | Month | 04 | 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
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preinitiation
Management information
Registered date
| 2020 | Year | 03 | Month | 03 | 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=R000045182
| Research Plan | |
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| 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 |
