UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of Evaluation of tumor cell content ratio using endocytoscopy in biopsy tissue.
Acronym	ECS4
Scientific Title	Assessment of Evaluation of tumor cell content ratio using endocytoscopy in biopsy tissue.
Scientific Title:Acronym	ECS4
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Endocytoscopy (ECS) is used to evaluate the tumor cell content on the spot using tissue specimens removed by bronchoscopy. Evaluate the rate of agreement with the tumor cell content of tissue samples submitted for pathological examination.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Is it possible to evaluate tumor cell content using ECS?
Key secondary outcomes	Is it possible to estimate the presence of malignant findings and tumor cell content by imprint cytology of tissue specimens?

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	1/3 of the obtained tissue specimen is immersed in 10% formalin for 30 seconds and semi-fixed, and then 0.5% methylene blue is applied. Do not use a tissue sample that is considered impossible to cut out and evaluate 1/3 because the sample obtained is small. Immediately after that, the tip of the ECS is brought into contact with the lesion, and an ultra-enlarged image of the specimen is observed to preserve the image findings.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) A case of bronchoscopy using EBUS-GS for localized lung disease. 2) Cases where a sufficient amount of tissue specimen that can be evaluated by ECS and pathological examination is expected to be obtained. 3) Age at consent is over 20 years old. 4) Explanation of the participation in the study is fully explained verbally and verbally, and consent is obtained in writing from the person.
Key exclusion criteria	1) Cases judged by the attending physician / inspection physician as inappropriate.
Target sample size	32

Research contact person
Name of lead principal investigator	1st name JUNRO Middle name Last name UMEMOTO
Organization	Shimane University
Division name	Respiratory medicine
Zip code	693-8501
Address	89-1 Enya-cho, Izumo-shi, Shimane
TEL	0853-20-2580
Email	jume@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name JUNRO Middle name Last name UMEMOTO
Organization	Shimane University
Division name	Respiratory medicine
Zip code	693-8501
Address	89-1 Enya-cho, Izumo-shi, Shimane
TEL	0853-20-2580
Homepage URL
Email	jume@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shimane University
Address	89-1 Enya-cho, Izumo-shi, Shimane
Tel	0853-88-3056
Email	kenkyu@med.shimane-u.ac.jp

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	2019 Year 11 Month 13 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	Preinitiation
Date of protocol fixation	2019 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date	2019 Year 11 Month 13 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 12 Day
Last modified on	2019 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043940