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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029291
Receipt No. 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

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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
Email 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
Email yhatanaka@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033487

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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