UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029291 |
|---|---|
| Receipt number | R000033487 |
| Scientific Title | An immunohistochemical analysis of PD-L1 and the related molecules in non-small cell lung cancer |
| Date of disclosure of the study information | 2017/09/27 |
| Last modified on | 2018/10/01 09:17:17 |
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Basic information
Public title
An immunohistochemical analysis of PD-L1 and the related molecules in non-small cell lung cancer
Acronym
An IHC analysis of PD-L1 and the related molecules in NCSLC
Scientific Title
An immunohistochemical analysis of PD-L1 and the related molecules in non-small cell lung cancer
Scientific Title:Acronym
An IHC analysis of PD-L1 and the related molecules in NCSLC
Region
| Japan |
Condition
Condition
Non small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinicopathological relationship among cancer immunity-related molecules (CIMs) including PD-L1 in NSCLCs, we analyze their immunohistochemical expressions
Basic objectives2
Others
Basic objectives -Others
Observational study for the purpose 1
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive ratio of CIMs
Key secondary outcomes
Correlation between CIM expressions and clinicopathological factors.
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
NSCLC cases diagnosed from January,2000 to December,2011 in Hokkaido University Hospital
Key exclusion criteria
Patients who is judged as not suitable in this study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Hatanaka |
Organization
Hokkaido University Hospital
Division name
Research Division of Companion Diagnostics
Zip code
Address
N14W5, Kita-ku, Sapporo
TEL
011-706-5716
yhatanaka@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Hatanaka |
Organization
Hokkaido University Hospital
Division name
Research Division of Companion Diagnostics
Zip code
Address
N14W5, Kita-ku, Sapporo
TEL
011-706-5716
Homepage URL
yhatanaka@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 27 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory Study
Management information
Registered date
| 2017 | Year | 09 | Month | 26 | Day |
Last modified on
| 2018 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033487
