UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016106 |
|---|---|
| Receipt number | R000018709 |
| Scientific Title | Endobronchial elastography for the diagnosis of intrathoracic malignancies during endobronchial ultrasound-guided transbronchial needle aspiration. |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2020/01/08 18:49:22 |
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Basic information
Public title
Endobronchial elastography for the diagnosis of intrathoracic malignancies during endobronchial ultrasound-guided transbronchial needle aspiration.
Acronym
Endobronchial elastography during EBUS-TBNA.
Scientific Title
Endobronchial elastography for the diagnosis of intrathoracic malignancies during endobronchial ultrasound-guided transbronchial needle aspiration.
Scientific Title:Acronym
Endobronchial elastography during EBUS-TBNA.
Region
| Japan |
Condition
Condition
Intrathoracic tumors
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical benefit of endobronchial elastography of convex probe endobronchial ultrasound during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for the diagnosis of intrathoracic tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In comparing between elastography images and pathological results, the primary outcome measures will be;
1) Sensitivity, 2) Specificity, 3) Positive predictive value, 4) Negative predictive value, 5) Accuracy in detecting malignancy
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The candidates of EBUS-TBNA
Key exclusion criteria
Inability to obtain consent.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yoshino |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of General Thoracic Surgery
Zip code
2608670
Address
1-8-1, Inohana, Chuo-ku, Chiba
TEL
043-222-7171
tnakajima76@hotmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Nakajima |
Organization
School of Medicine, Chiba University
Division name
Department of General Thoracic Surgery
Zip code
2608670
Address
1-8-1, Inohana, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
takahiro_nakajima@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Chiba University Graduate School of Medicine
Address
1-8-1, Inohana, Chuo-ku, Chiba
Tel
043-222-7171
igaku-rinri@office.chiba-u.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
| 2015 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
122
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
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In comparison between endobronchial elastography and pathological results, the primary outcome measurement will be;
1) Sensitivity, 2) Specificity, 3) Positive predictive value, 4) Negative predictive value, 5) Accuracy in detecting intrathoracic malignancies
Management information
Registered date
| 2015 | Year | 01 | Month | 04 | Day |
Last modified on
| 2020 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018709
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
