UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052314 |
|---|---|
| Receipt number | R000059579 |
| Scientific Title | Development of Novel Immunotherapy for Cancer |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/09/26 13:19:40 |
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Basic information
Public title
Development of Novel Immunotherapy for Cancer
Acronym
Development of Novel Immunotherapy for Cancer
Scientific Title
Development of Novel Immunotherapy for Cancer
Scientific Title:Acronym
Development of Novel Immunotherapy for Cancer
Region
| Japan |
Condition
Condition
Liquid and Solid Tumors
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Assessment of novel cell and antibody products developed by synthetic biology approaches and their translation into the clinic.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy and safety of gene-modified immune cells and antibodies.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Donors and Cancer Patients
Key exclusion criteria
Donors whose Hb values are less than 9.0 g/dL.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Ochi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Hematology, Clinical Immunology and Infectious Diseases
Zip code
791-0295
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5296
ochi.toshiki.eg@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Ochi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Hematology, Clinical Immunology and Infectious Diseases
Zip code
791-0295
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5296
Homepage URL
ochi.toshiki.eg@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Ehime University Hospital, Clinical Therapeutic Trial Center
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5914
cttc@m.ehime-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
| 2023 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2031 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Development of novel immunotherapy using human samples.
Management information
Registered date
| 2023 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059579
