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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038017
Receipt No. 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

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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
Email 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
Email tojima@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University School of Medicine Second Department of Surgery
Institute
Department

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
Email 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
URL(English) https://upload.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


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