UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An immunohistochemical analysis of PD-L1 and the related molecules in non-small cell lung cancer
Title of the study (Brief title)	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	Yutaka Hatanaka
Organization	Hokkaido University Hospital
Division name	Research Division of Companion Diagnostics
Address	N14W5, Kita-ku, Sapporo
TEL	011-706-5716
Email	yhatanaka@huhp.hokudai.ac.jp

Public contact
Name of contact person	Yutaka Hatanaka
Organization	Hokkaido University Hospital
Division name	Research Division of Companion Diagnostics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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