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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030800
Receipt No. R000035171
Scientific Title Usefulness of PD-L1 evaluation using a large number of biopsy specimens for the prediction of nivolumab efficacy
Date of disclosure of the study information 2018/01/14
Last modified on 2018/01/15

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Basic information
Public title Usefulness of PD-L1 evaluation using a large number of biopsy specimens for the prediction of nivolumab efficacy
Acronym Usefulness of PD-L1 evaluation using a large number of biopsy specimens for the prediction of nivolumab efficacy
Scientific Title Usefulness of PD-L1 evaluation using a large number of biopsy specimens for the prediction of nivolumab efficacy
Scientific Title:Acronym Usefulness of PD-L1 evaluation using a large number of biopsy specimens for the prediction of nivolumab efficacy
Region
Japan

Condition
Condition non small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of PD-L1 evaluations using a large number of biopsy specimens for the prediction of nivolumab efficacy, compared with the evaluation of only one biopsy specimen.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The most suitable number of biopsy specimens for the prediction of nivolumab efficacy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Between Jan. 2016 and Aug. 2018, NSCLC patients recieved nivolumab at National Cancer Center Hospital East and National Cancer Center Hospital.
Key exclusion criteria none
Target sample size 357

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Goto
Organization National Cancer Center Hospital East
Division name Thoracic Oncology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email kgoto@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hibiki Udagawa
Organization National Cancer Center Hospital East
Division name Thoracic Oncology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email hudagawa@east.ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Ono Pharmaceutical Co., LTD.
Bristol-Meyers 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
2018 Year 01 Month 14 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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 01 Month 14 Day
Last modified on
2018 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035171

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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