UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025395 |
|---|---|
| Receipt number | 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 | 2021/01/07 09:04:49 |
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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 | Tomohito |
| Middle name | |
| Last name | SAITO |
Organization
Kansai Medical University
Division name
Department of Thoracic Surgery
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata, Osaka, 5731010, JAPAN
TEL
072-804-0101
saitotom@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Tomohito |
| Middle name | |
| Last name | SAITO |
Organization
Kansai Medical University
Division name
Department of Thoracic Surgery
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata, Osaka, 5731010, JAPAN
TEL
072-804-0101
Homepage URL
saitotom@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
Kansai Medical University Hospital Research Ethics Board
Address
2-5-1 Shinmachi, Hirakata, Osaka, 5731010, JAPAN
Tel
072-804-0101
rinriirb@hirakata.kmu.ac.jp
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
https://www.lungcancerjournal.info/article/S0169-5002(18)30589-0/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.lungcancerjournal.info/article/S0169-5002(18)30589-0/fulltext
Number of participants that the trial has enrolled
420
Results
General agreement in tumoral PD-L1 detection between 22C3 and 28-8 was satisfactory.
Dako 22C3 revealed a significantly higher tumoral PD-L1 expression compared to 28-8.
Positive results of 22C3 (reference) and those of 28-8 (comparator) showed discordance.
The results of 28-8 could be translated to those of 22C3 but not vice versa.
Results date posted
| 2021 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 10 | Month | 05 | Day |
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
| 2016 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029066
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