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

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 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


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

Value
https://center6.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