UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038017 |
|---|---|
| Receipt number | R000043190 |
| Scientific Title | Basic research on neoantigen analysis in patients with gastrointestinal solid cancer |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2019/09/17 07:11:57 |
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Basic information
Public title
Basic research on neoantigen analysis in patients with gastrointestinal solid cancer
Acronym
Basic research on neoantigen analysis in patients with gastrointestinal solid cancer
Scientific Title
Basic research on neoantigen analysis in patients with gastrointestinal solid cancer
Scientific Title:Acronym
Basic research on neoantigen analysis in patients with gastrointestinal solid cancer
Region
| Japan |
Condition
Condition
gastrointestinal solid cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We will investigate whether dendritic cells derived from induced pluripotent stem cells(iPSDCs) transfected with in vitro transcription RNA(ivtRNA) can induce neoantigen specific cytotoxic T cells(CTLs).
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tumor-specific CTLs are induced by iPSDCs-ivtRNA derived from cancer-bearing patients to evaluate the immune response against neoantigen.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The gastrointestinal tract is the primary, and pathologically diagnosed as adenocarcinoma or squamous cell carcinoma.
2. The registration date is over 20 years old.
3. Performance status (PS) is 0 to 1.
4. No history of chemotherapy, radiation therapy, endocrine therapy, or immunosuppressive therapy, including other carcinomas.
5. Organ function is maintained.
6. The patient has given written consent to participate in the study.
Key exclusion criteria
The patient has not given written consent.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama Medical University School of Medicine
Division name
Second Department of Surgery
Zip code
6418509
Address
811-1 Kimiidera, Wakayama 641-8510, Japan.
TEL
073-441-0613
tojima@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama Medical University School of Medicine
Division name
Second Department of Surgery
Zip code
6418509
Address
811-1 Kimiidera, Wakayama 641-8510, Japan.
TEL
073-441-0613
Homepage URL
tojima@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University School of Medicine Second Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University Ethics Review Board
Address
811-1 Kimiidera, Wakayama 641-8510, Japan.
Tel
073-441-0896
wa-rinri@wakayama-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
| 2019 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will investigate whether dendritic cells derived from induced pluripotent stem cells(iPSDCs) transfected with in vitro transcription RNA(ivtRNA) can induce neoantigen specific cytotoxic T cells(CTLs).
Management information
Registered date
| 2019 | Year | 09 | Month | 17 | Day |
Last modified on
| 2019 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043190
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
