UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040280 |
|---|---|
| Receipt number | R000045957 |
| Scientific Title | Research to elucidate the anti-tumor immune responses and develop the combination therapy in solid tumor |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2023/12/20 16:51:11 |
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Basic information
Public title
Research to elucidate the anti-tumor immune responses and develop the combination therapy in solid tumor
Acronym
Research to elucidate the anti-tumor immune responses and develop the combination therapy in solid tumor
Scientific Title
Research to elucidate the anti-tumor immune responses and develop the combination therapy in solid tumor
Scientific Title:Acronym
Research to elucidate the anti-tumor immune responses and develop the combination therapy in solid tumor
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Profiling of state of tumor and immune responses at solid tumor from clinical patients.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of tumor cells and immune cells in tumor microenvironment and peripheral blood.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who doubted solid tumor in clinically or confirmed solid tumor histologically.
2) Patients who plan to give biopsy or surgery.
3) Patients who gave informed consent by oneself.
Key exclusion criteria
The cases an attending physician determined ineligible.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Tahara |
Organization
Osaka International Cancer Institute, Research center
Division name
Department of Cancer Drug Discovery and Development
Zip code
541-8567
Address
3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka
TEL
06-6945-1181
tahara@ims.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Mizote |
Organization
Osaka International Cancer Institute, Research center
Division name
Department of Cancer Drug Discovery and Development
Zip code
541-8567
Address
3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka
TEL
06-6945-1181
Homepage URL
https://oici.jp/file/houkatu/ken-gansouyaku-01-4.pdf
mizote-yu@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute, Research center
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Cancer Institute, Clinical research administration Control center
Address
3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka
Tel
06-6945-1181
rinri01@opho.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
| 2020 | Year | 05 | 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
80
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 05 | Month | 01 | Day |
Last modified on
| 2023 | 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=R000045957
