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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034575
Receipt No. 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

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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
Email 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
Email ka07-miyazaki@city.yokohama.jo

Sponsor
Institute Yokohama municipal CItizens Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034443

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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