UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034575 |
|---|---|
| Receipt number | R000034443 |
| Scientific Title | Observational study comparing the staining property of PD-L1 using past specimens of non-small cell lung carcinoma pleural effusion cell block with that of general tissue specimens. |
| Date of disclosure of the study information | 2018/10/25 |
| Last modified on | 2018/10/19 16:48:04 |
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Basic information
Public title
Observational study comparing the staining property of PD-L1 using past specimens of non-small cell lung carcinoma pleural effusion cell block with that of general tissue specimens.
Acronym
Observational study comparing the the staining property of PD-L1 of non-small cell lung carcinoma pleural effusion cell block.
Scientific Title
Observational study comparing the staining property of PD-L1 using past specimens of non-small cell lung carcinoma pleural effusion cell block with that of general tissue specimens.
Scientific Title:Acronym
Observational study comparing the the staining property of PD-L1 of non-small cell lung carcinoma pleural effusion cell block.
Region
| Japan |
Condition
Condition
non-small cell lung carcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Immunohistochemical staining (IHC) of PD-L1 with pleural effusion cell block was performed using past specimen and it is compared with general stainability in the tissue specimen.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immunohistochemical staining of PD-L1 in pleural effusion cell block.
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
PD-L1 for all specimens of patients with non-small cell lung cancer patients who obtained pleural effusion cell block Yokohama City Municipal Hospital Respiratory Medicine Department in the past 3 years, excluding those refused by the patient, Perform inspection.
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhito MIyazaki |
Organization
Yokohama municipal CItizens Hospital
Division name
Respiratory medicine
Zip code
Address
56, okazawacho, Hodogaya-ku, Yokohama-shi, Kanagawa, Japan
TEL
045-331-1961
ka07-miyazaki@city.yokohama.jo
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhito MIyazaki |
Organization
Yokohama municipal CItizens Hospital
Division name
Respiratory medicine
Zip code
Address
56, okazawacho, Hodogaya-ku, Yokohama-shi, Kanagawa, Japan
TEL
045-331-1961
Homepage URL
ka07-miyazaki@city.yokohama.jo
Sponsor or person
Institute
Yokohama municipal CItizens Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama municipal CItizens Hospital Respiratory medicine
Organization
Division
Category of Funding Organization
Self funding
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 | 10 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Immunohistochemical staining of PD-L1 in pleural effusion cell block is performed. After that, PD-L1 staining ratio of pleural effusion cell block and PD - L1 staining ratio in general tissue specimen are compared.
Management information
Registered date
| 2018 | Year | 10 | Month | 19 | Day |
Last modified on
| 2018 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034443
