UMIN-CTR Clinical Trial

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
Email	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
Email	tanimine@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045182