UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032851 |
|---|---|
| Receipt number | R000037450 |
| Scientific Title | Analysis of tumor-associated antigen expressions and immune responses using clinical samples |
| Date of disclosure of the study information | 2018/06/04 |
| Last modified on | 2022/12/20 15:44:37 |
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Basic information
Public title
Analysis of tumor-associated antigen expressions and immune responses using clinical samples
Acronym
Analysis of tumor-antigen expressions and immune responses
Scientific Title
Analysis of tumor-associated antigen expressions and immune responses using clinical samples
Scientific Title:Acronym
Analysis of tumor-antigen expressions and immune responses
Region
| Japan |
Condition
Condition
malignant tumors, healthy volunteers
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Surgery in general |
| Pediatrics | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis and evaluation of zing tumor-associated antigen expression on tumor tissues and immune responses in peripheral blood and tumor sites
Basic objectives2
Others
Basic objectives -Others
Exploration of prediction biomarker for immunotherapy efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Tumor antigen expressions
immune responses in peripheral blood and tumor sites(in possible cases)
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient having malignant tuomors (including esophageal cancer, gastric cancer, colon cancer, gynecological cancer, head/neck cancer, urological cancer, bone and soft tissue cancer, and hematological malignancy, et al), who is aged 12 years or older
Healthy volunteer as a control, who is aged 20 years or older
Key exclusion criteria
No obtaining an informed consent
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Miyahara |
Organization
Mie University Graduate School of Medicine
Division name
Personalized Cancer Immunotherapy
Zip code
514-8507
Address
2-174, Ebobashi, Tsu, Mie 514-8507 Japan
TEL
059-231-5684
miyahr-y@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Miyahara |
Organization
Mie University Graduate School of Medicine
Division name
Personalized Cancer Immunotherapy
Zip code
514-8507
Address
2-174, Ebobashi, Tsu, Mie 514-8507 Japan
TEL
059-231-5684
Homepage URL
miyahr-y@med.mie-u.ac.jp
Sponsor or person
Institute
Personalized Cancer Immunotherapy, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fundings under the agreements between T cell Neuvue Co. Ltd. and Mie University
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
Ethics Committee in Mie University Hospital
Address
2-174, Ebobashi, Tsu, Mie 514-8507 Japan
Tel
059-231-5045
s-kenkyu@mo.medic.mie-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
名古屋医療センター(愛知県）、東京医科大学（東京都）、産業技術総合研究所（神奈川県）、北海道大学（北海道）、大阪国際医療センター（大阪府）、鹿児島大学（鹿児島県）、獨協医科大学（栃木県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 06 | Month | 03 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037450
