UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024500 |
|---|---|
| Receipt number | R000027116 |
| Scientific Title | Evaluation of the immune-profiling for patients participating in Phase Ib/II Study of BBI608 in Combination with Pembrolizumab and the relationship between the immune-profiling and efficacy using paired biopsies and peripheral blood. |
| Date of disclosure of the study information | 2016/10/20 |
| Last modified on | 2025/03/28 10:31:56 |
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Basic information
Public title
Evaluation of the immune-profiling for patients participating in Phase Ib/II Study of BBI608 in Combination with Pembrolizumab and the relationship between the immune-profiling and efficacy using paired biopsies and peripheral blood.
Acronym
SCOOP BM study
Scientific Title
Evaluation of the immune-profiling for patients participating in Phase Ib/II Study of BBI608 in Combination with Pembrolizumab and the relationship between the immune-profiling and efficacy using paired biopsies and peripheral blood.
Scientific Title:Acronym
SCOOP BM study
Region
| Japan |
Condition
Condition
metastatic colorectal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of the immune-profiling for patients participating in Phase Ib/II Study of BBI608 in Combination with Pembrolizumab and the relationship between the immune-profiling and efficacy using paired biopsies and peripheral blood.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the immune-profiling.
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)Participate in SCOOP study
2)Patients who can provide written informed consent
Key exclusion criteria
1)Patients who are unfit for the study as determined by the attending physician
Target sample size
59
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Yoshino |
Organization
National Cancer Center Hospital East
Division name
Gastrointestinal Oncology Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
scoop_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasutoshi Kuboki/Akihito Kawazoe |
Organization
National Cancer Center Hospital East
Division name
Department of Experimental Therapeutics and GI Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
scoop_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Project of Translational and Clinical Research Core Centers
IRB Contact (For public release)
Organization
Address
Tel
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
国立がん研究センター東病院（千葉県）
四国がんセンター（愛媛県）
埼玉がんセンター（埼玉県）
北海道大学病院（北海道）
がん研究会有明病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is the additional study in UMIN's unique trial number UMIN000023149.
Management information
Registered date
| 2016 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027116
