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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000032178
Receipt No. R000036680
Scientific Title Comparison of Two PD-L1 diagnostic Tests
Date of disclosure of the study information 2018/04/15
Last modified on 2018/12/29

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Basic information
Public title Comparison of Two PD-L1 diagnostic Tests
Acronym Comparison of PD-L1 IHC
Scientific Title Comparison of Two PD-L1 diagnostic Tests
Scientific Title:Acronym Comparison of PD-L1 IHC
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 concordance of the two PD-L1 IHC assay systems (SP263 and 22c3).
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate concordance of the two PD-L1 IHC assay systems (SP263 and 22c3).
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria NSCLC patients who received complete resection at our institute.
Key exclusion criteria Surgical tissue blocks older than 1 year.
Patients who received neoadjubant radiotherapy or chemotherapy.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daichi Fujimoto
Organization Kobe city medical center general hospital
Division name Division of respiratory medicine
Zip code
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL 078-302-4321
Email daichi@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daichi Fujimoto
Organization Kobe city medical center general hospital
Division name Division of respiratory medicine
Zip code
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL 078-302-4321
Homepage URL
Email daichi@kcho.jp

Sponsor
Institute Kobe city medical center general hospital
Institute
Department

Funding Source
Organization Astrazeneca
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 04 Month 15 Day

Related information
URL releasing protocol
Publication of results 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
2018 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 10 Month 20 Day

Other
Other related information Two pathologists independently scored all immunostained slides.
Tumor proportion scores (TPSs) of PD-L1 in tumor cell (TC) were expressed as the percentage of PD-L1-positive TCs in
the overall tumor sections and estimated in increments of 5%.

Management information
Registered date
2018 Year 04 Month 10 Day
Last modified on
2018 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036680

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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