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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025395
Receipt No. R000029066
Scientific Title Investigating the impact of programmed cell death logand-1 (PD-L1) expression in lung cancer on long-term outcome and therapeutic effect of anti-programmed cell death-1 antibody agents.
Date of disclosure of the study information 2016/12/24
Last modified on 2018/10/07

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Basic information
Public title Investigating the impact of programmed cell death logand-1 (PD-L1) expression in lung cancer on long-term outcome and therapeutic effect of anti-programmed cell death-1 antibody agents.
Acronym Investigating the impact of PD-L1 expression in lung cancer on long-term outcome and therapeutic effect of anti-PD-1 antibody agents.
Scientific Title Investigating the impact of programmed cell death logand-1 (PD-L1) expression in lung cancer on long-term outcome and therapeutic effect of anti-programmed cell death-1 antibody agents.
Scientific Title:Acronym Investigating the impact of PD-L1 expression in lung cancer on long-term outcome and therapeutic effect of anti-PD-1 antibody agents.
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To (semi-)quantify the protein expression of PD-L1 in lung cancer by immunohistochemical stain and
Basic objectives2 Others
Basic objectives -Others To investigate the impact of PD-L1 expression in lung cancer on long-term outcome and therapeutic effect of anti-PD-1 antibody agents
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Protein expression of PD-L1 in lung cancer tissue
Key secondary outcomes #1 Overall survival according to PD-L1 expression

#2 Recurrence-free survival according to PD-L1 expression in patients undergoing complete resection for their lung cancer

#3 Progression-free survival according to PD-L1 expression in patients receiving anti-PD-1 antibody agents

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Quantification of PD-L1 expression in histopathological specimen (by immunohistochemical analysis)
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 All the patients with lung cancer undergoing surgery or receiving anti-PD-1 antibody agents between January 1st of 2006 and December 31st of 2015 EXCEPT those matching the following exclusion criteria.
Key exclusion criteria #1 Patients with inadequate amount of their pathological sample for this study

#2 Patients refusing to be enrolled in this study

#3 Patients who is judged as not suitable by the administrator of this study
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohito SAITO
Organization Kansai Medical University
Division name Department of Thoracic Surgery
Zip code
Address 2-5-1 Shinmachi, Hirakata, Osaka, 5731010, JAPAN
TEL 072-804-0101
Email saitotom@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohito SAITO
Organization Kansai Medical University
Division name Department of Thoracic Surgery
Zip code
Address 2-5-1 Shinmachi, Hirakata, Osaka, 5731010, JAPAN
TEL 072-804-0101
Homepage URL
Email saitotom@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Bristol-Myers Squibb Company
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
2016 Year 12 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2016 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 24 Day
Last modified on
2018 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029066

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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