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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033817
Receipt No. R000038574
Scientific Title Assessment of usefulness of endocytoscopy for evaluation of transbronchial biopsy specimens
Date of disclosure of the study information 2018/08/20
Last modified on 2018/08/20

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Basic information
Public title Assessment of usefulness of endocytoscopy for evaluation of transbronchial biopsy specimens
Acronym Usefulness of endocytoscopy for evaluation of transbronchial biopsy specimens
Scientific Title Assessment of usefulness of endocytoscopy for evaluation of transbronchial biopsy specimens
Scientific Title:Acronym Usefulness of endocytoscopy for evaluation of transbronchial biopsy specimens
Region
Japan

Condition
Condition Benign or malignant pulmonary leision
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate volume of biopsy specimens and diagnostic accuracy of pulmonary lesions usingthe endocytoscopy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic yield using ECS
Key secondary outcomes Time of procedure
Diagnostic yield according to benign or malignant
intra-observer agreement
inter-observer agreement

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patient with a peripheral pulmonary lesion 30mm<= in size who need to undergo EBUS-GS
2.Informed consent
Key exclusion criteria 1.Clinical difficulties in this trial
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takae Okuno
Organization Shimane University Hospital
Division name Medical Oncology and Respiratory Medicine
Zip code
Address 89-1 Enya-cho Izumo-shi shimane, Japan
TEL 0853-20-2580
Email takae007@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takae Okuno
Organization Shimane University Hospital
Division name Medical Oncology and Respiratory Medicine
Zip code
Address 89-1 Enya-cho Izumo-shi shimane, Japan
TEL 0853-20-2580
Homepage URL
Email takae007@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Hospital
Medical Oncology and Respiratory Medicine
Institute
Department

Funding Source
Organization Shimane University Hospital
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 島根大学医学部附属病院(島根県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 20 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 08 Month 20 Day
Last modified on
2018 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038574

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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