UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031571 |
|---|---|
| Receipt number | R000036046 |
| Scientific Title | Transbronchial Ultrasound frequency analysis for the evaluation of peripheral pulmonary nodules |
| Date of disclosure of the study information | 2018/03/05 |
| Last modified on | 2018/03/04 22:27:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Transbronchial Ultrasound frequency analysis for the evaluation of peripheral pulmonary nodules
Acronym
Transbronchial Ultrasound frequency analysis for peripheral pulmonary nodules.
Scientific Title
Transbronchial Ultrasound frequency analysis for the evaluation of peripheral pulmonary nodules
Scientific Title:Acronym
Transbronchial Ultrasound frequency analysis for peripheral pulmonary nodules.
Region
| Japan |
Condition
Condition
abnormal pulmonary infiltrates
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop the evaluation system for peripheral pulmonary nodules before sampling.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between ultrasound frequency feature parameters and diagnosis of peripheral pulmonary nodules
Key secondary outcomes
The sensitivity and specificity of ultrasound frequency feature parameters for diagnosis of peripheral pulmonary nodules
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Candidates for bronchoscopy to evaluate peripheral pulmonary nodules.
Key exclusion criteria
Without using radial endobronchial ultrasound probe.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsukasa Ishiwata |
Organization
Chiba University
Division name
Department of respirology
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
ishiwatat@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsukasa Ishiwata |
Organization
Chiba University
Division name
Department of respirology
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
ishiwatat@chiba-u.jp
Sponsor or person
Institute
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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 05 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Collect data of ultrasound frequency feature parameters and of diagnosis of peripheral pulmonary nodules.
2. Examine the association between variables above.
Management information
Registered date
| 2018 | Year | 03 | Month | 04 | Day |
Last modified on
| 2018 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036046
