UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043113 |
|---|---|
| Receipt number | R000049220 |
| Scientific Title | Accompanying research No. 2 of "Analyses of immune status in malignant tumor patients": analysis of immune status of the tumor microenvironment in esophageal cancer patients treated with PD-1 blockade therapy |
| Date of disclosure of the study information | 2021/01/25 |
| Last modified on | 2021/01/24 16:06:19 |
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Basic information
Public title
Analysis of immune status of the tumor microenvironment in esophageal cancer patients treated with PD-1 blockade therapy
Acronym
PD-1 blockade therapy and immune status of the tumor microenvironment in esophageal cancer patients
Scientific Title
Accompanying research No. 2 of "Analyses of immune status in malignant tumor patients": analysis of immune status of the tumor microenvironment in esophageal cancer patients treated with PD-1 blockade therapy
Scientific Title:Acronym
Analysis of immune status of the tumor microenvironment in esophageal cancer patients treated with PD-1 blockade therapy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the association between efficacy of PD-1 blockade therapy and immune profiling in esophageal cancer patients
Basic objectives2
Others
Basic objectives -Others
Translational research
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between efficacy of PD-1 blockade therapy and 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
Esophageal patients who joined in "Analyses of immune status in malignant tumor patients" and agreed with secondary use
Key exclusion criteria
Clinicians judge as ineligible cases.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Amanuma |
Organization
Chiba Cancer Center
Division name
Clinical Trial Promotion Department
Zip code
260-8717
Address
666-2, Nitona-cho, Chuo-ku, Chiba
TEL
0432645431
yamanuma@chiba-cc.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Togashi |
Organization
Chiba Cancer Center
Division name
Research Institute
Zip code
260-8717
Address
666-2, Nitona-cho, Chuo-ku, Chiba
TEL
0432645431
Homepage URL
ytogashi@chiba-cc.jp
Sponsor or person
Institute
Chiba Cancer Center
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD. and Bristol-Myers Squibb K.K.
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
Chiba Cancer Center
Address
666-2, Nitona-cho, Chuo-ku, Chiba
Tel
0432645431
rinshokenkyu@chiba-cc.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
| 2021 | Year | 01 | Month | 25 | 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
| 2020 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2021 | Year | 01 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049220
