UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016062 |
|---|---|
| Receipt number | R000018666 |
| Scientific Title | Utility of rapid on-site cytological evaluation during Endobrohchial ultrasound-guided transbronchial needle aspiration |
| Date of disclosure of the study information | 2015/01/15 |
| Last modified on | 2017/07/28 10:09:32 |
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Basic information
Public title
Utility of rapid on-site cytological evaluation during Endobrohchial ultrasound-guided transbronchial needle aspiration
Acronym
Utility of ROSE during EBUS-TBNA
Scientific Title
Utility of rapid on-site cytological evaluation during Endobrohchial ultrasound-guided transbronchial needle aspiration
Scientific Title:Acronym
Utility of ROSE during EBUS-TBNA
Region
| Japan |
Condition
Condition
diseases causeing hilar and mediastinal lymphadenopathy (malignancy, sarcodosis, etc)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to explore the utility of Rapid on-site cytological evaluation (ROSE) during endobronchial ultrasound-guided needle aspiration (EBUS-TBNA)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic yields
Key secondary outcomes
the length of the examination for EBUS-TBNA, the number of needle aspirations per patient, complications, and additional examinations needed
Base
Study type
Others,meta-analysis etc
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
patients who had undergone EBUS-TBNA for the diagnosis of mediastinal and/or hilar lymphadenopathy
Key exclusion criteria
none
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mari Yamasue |
Organization
Oita university faculty of medicine
Division name
Department of respiratory medicine and infectious diseases
Zip code
Address
Hasama-machi Idaigaoka 1-1, Yufu-city, Oita, Japan
TEL
097-586-5804
sai-mari@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Yamasue |
Organization
Oita university faculty of medicine
Division name
Department of respiratory medicine and infectious diseases
Zip code
Address
Hasama-machi Idaigaoka 1-1, Yufu-city, Oita, Japan
TEL
097-586-5804
Homepage URL
sai-mari@oita-u.ac.jp
Sponsor or person
Institute
Oita university faculty of medicine, Department of respiratory medicine and infectious diseases
Institute
Department
Personal name
Funding Source
Organization
Oita university faculty of medicine, Department of respiratory medicine and infectious diseases
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
大分大学医学部附属病院 呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 15 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective analysis of patients who had undergone EBUS-TBNA for the diagnosis of mediastinal and (or) hilar lymphadenopathy between January 2012 and November 2014. We compare the following points between the groups of patients who underwent EBUS-TBNA with or without ROSE.
Management information
Registered date
| 2014 | Year | 12 | Month | 26 | Day |
Last modified on
| 2017 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018666
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
