UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021105 |
|---|---|
| Receipt number | R000024348 |
| Scientific Title | Basic research of immunotherapy using dendritic cells derived from induced pluripotent stem cells in healthy donors and cancer patients |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2020/02/22 10:12:20 |
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Basic information
Public title
Basic research of immunotherapy using dendritic cells derived from induced pluripotent stem cells in healthy donors and cancer patients
Acronym
Basic research of immunotherapy using dendritic cells derived from induced pluripotent stem cells in healthy donors and cancer patients
Scientific Title
Basic research of immunotherapy using dendritic cells derived from induced pluripotent stem cells in healthy donors and cancer patients
Scientific Title:Acronym
Basic research of immunotherapy using dendritic cells derived from induced pluripotent stem cells in healthy donors and cancer patients
Region
| Japan |
Condition
Condition
Advanced or recurrent gastrointestinal cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the capacity of dendritic cells (DCs) derived from iPS cells in healthy donors and cancer patients to prime tumor-associated antigen (TAA)-specific cytotoxic T cells (CTLs) in vitro
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the capacity of the DCs derived from iPS cells in healthy donors and cancer patients to prime TAA-specific CTLs comparatively with the DCs derived from peripheral blood mononuclear cells (PBMCs) in the donors and the patients
Key secondary outcomes
To investigate the morphology of the DCs derived from iPS cells in healthy donors and cancer patients comparatively with the DCs derived from PBMCs in the donors and the patients
To investigate the capacity in terms of maturation and migration of the DCs derived from iPS cells in healthy donors and cancer patients comparatively with the DCs derived from PBMCs in the donors and the patients
To verify the expression of tumor associated antigen in cancer cells sampled from cancer patients
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Collection of blood sample up to 50ml
Sampling cancer tissue from cancer patients within the necessary to treat the patients
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Advanced or recurrent gastrointestinal cancer confirmed adenocarcinoma or squamous cell carcinoma
2)Over clinical StageIII in UICC-TNM
3)Aged from 20 to 75 years
4)Performance status 0 or 1
5)Patient who has never had chemotherapy, radiation therapy, and endocrine therapy for cancer
6)Sufficient functions of major organ
7)Full filling the following conditions within 2 weeks before registration
WBC from 4,000/mm3 to 12,000/mm3.
Neutrophils over 2,000/mm3.
Hemoglobin over 8.0g/dL.
Plate over 100,000/mm3.
AST under 100IU/L, or ALT under 100IU/L.
Total bilirubin under 1.5mg/dL.
Serum creatinine under 1.2mg/dL.
Creatinine clearance over 60mL/min/body.
8)Having written informed consent
Key exclusion criteria
1)Active other malignancy, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable
2)Pregnant or lactating woman
3)Sever mental impairment
4)Active or uncontrolled clinically serious infection, except local infection not influencing general status
5)Judged inappropriate by the investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
tojima@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Tabata |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
Homepage URL
htabata@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgery, Wakayama Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Department of Surgery, Wakayama Medical University, School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Second Department of Surgery, Wakayama Medical University
Address
Kimiidera 811-1 Wakayama
Tel
0734410613
tojima@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
和歌山県立医科大学病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 19 | Day |
Last modified on
| 2020 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024348
