UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comprehensive analysis to identify transcriptomic signatures that positively or negatively correlate with clinical outcome of nivolumab monotherapy in patients with non-small cell lung carcinoma
Title of the study (Brief title)	CTSN study
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Medicine in general Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To identify and validate transcriptomic signatures as robust predictive biomarkers for nivolumab monotherapy in patients with NSCLC
Basic objectives2	Others
Basic objectives -Others	Biomarker screening
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Identification of transcriptomic signatures that positively or negatively correlate with clinical outcome of nivolumab monotherapy
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) Subjects with histologically or cytologically-diagnosed NSCLC. 2) Subjects who are judged suitable for nivolumab monotherapy by investigators. 3) Recent fresh frozen tumor samples must be available for biomarker evaluation.
Key exclusion criteria	1) Subjects with a condition requiring systemic treatment with either systemic corticosteroids or other immunosuppressive medications within 14 days of first nivolumab administration.
Target sample size	40

Research contact person
Name of lead principal investigator	Shunichi Sugawara
Organization	Sendai Kosei Hospital
Division name	Respiratory medicine
Address	4-15, Hirosemachi, Aoba-ku, Sendai-shi, Miyagai-ken, Japan
TEL	81-22-222-6181
Email	swara357@cat-v.ne.jp

Public contact
Name of contact person	Tomoiki Aiba
Organization	Sendai Kosei Hospital
Division name	Respiratory medicine
Address	4-15, Hirosemachi, Aoba-ku, Sendai-shi, Miyagai-ken, Japan
TEL	81-22-222-6181
Homepage URL
Email	tomowithkk@gmail.com

Sponsor
Institute	Sendai Kosei Hospital
Institute
Department

Funding Source
Organization	Ono Pharmaceutical Co., Ltd. Bristol-Myers Squibb Co.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Division of Health Medical Computational Science, Health Intelligence Center, The Institute of Medical Science, The University of Tokyo Laboratory of Systems Genomics, Department of Computational Biology and Medical Sciences, Graduate School of Frontier Sciences, The University of Tokyo
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	仙台厚生病院

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 21 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 28 Day
Anticipated trial start date	2017 Year 05 Month 22 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	N/A

Management information
Registered date	2017 Year 04 Month 21 Day
Last modified on	2018 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030878