UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027413 |
|---|---|
| Receipt number | R000031414 |
| Scientific Title | Prospective analyses of immunne response to establish of predictive biomarker of anti-cancer immunotherapies effect in solid tumor |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2023/05/24 15:53:14 |
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Basic information
Public title
Prospective analyses of immunne response to establish of predictive biomarker of anti-cancer immunotherapies effect in solid tumor
Acronym
Prospective analyses of immunne response to establish of predictive biomarker of anti-cancer immunotherapies effect in solid tumor
Scientific Title
Prospective analyses of immunne response to establish of predictive biomarker of anti-cancer immunotherapies effect in solid tumor
Scientific Title:Acronym
Prospective analyses of immunne response to establish of predictive biomarker of anti-cancer immunotherapies effect in solid tumor
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish of predictive biomarker of anti-cancer immunotherapies effect in solid tumor
Basic objectives2
Others
Basic objectives -Others
To investigate mechanism of anti-cancer immunotherapies resistance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To establish of predictive biomarker of anti-cancer immunotherapies effect in solid tumor
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. Histologically or cytologically confirmed diagnosis of solid tumor (aged 20 years or older)
2. Immune checkpoint inhibitors treatment are planned
3. Biopsy of tumor tissue is planned for diagnoses
4. Drawing 30mL peripheral blood is considered proper
Key exclusion criteria
None
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Nishikawa |
Organization
National Cancer Center Hospital East
Division name
Division of Cancer Immunology
Zip code
277-8577
Address
6-5-1 kashiwanoha kashiwa chiba
TEL
0471331111
hnishika@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Koyama |
Organization
National Cancer Center Hospital East
Division name
Division of Cancer Immunology
Zip code
277-8577
Address
6-5-1 kashiwanoha kashiwa chiba
TEL
0471331111
Homepage URL
esugiyam@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
National Cancer Center Institutional Review Board
Address
6-5-1 kashiwanoha kashiwa chiba
Tel
0471331111
irst@ml.res.ncc.go.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
がん研究会 有明病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 22 | 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 | 12 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study
Management information
Registered date
| 2017 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031414
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
