UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032178 |
|---|---|
| Receipt number | R000036680 |
| Scientific Title | Comparison of Two PD-L1 diagnostic Tests |
| Date of disclosure of the study information | 2018/04/15 |
| Last modified on | 2022/01/09 08:16:58 |
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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
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
daichi@kcho.jp
Sponsor or person
Institute
Kobe city medical center general hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 08 | Day |
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
| 2022 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036680
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
