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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027092
Receipt No. R000030878
Scientific Title 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
Date of disclosure of the study information 2017/04/21
Last modified on 2018/10/25

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Basic information
Public title 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
Acronym CTSN study
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Shunichi Sugawara
Organization Sendai Kosei Hospital
Division name Respiratory medicine
Zip code
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
1st name
Middle name
Last name Tomoiki Aiba
Organization Sendai Kosei Hospital
Division name Respiratory medicine
Zip code
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)

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 仙台厚生病院

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 21 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 Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 28 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000030878

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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