UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026934 |
|---|---|
| Receipt number | R000030897 |
| Scientific Title | Spectrum analysis of endobronchial ultrasound radiofrequency for the prediction of intrathoracic malignancy |
| Date of disclosure of the study information | 2017/04/11 |
| Last modified on | 2018/04/16 15:18:05 |
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Basic information
Public title
Spectrum analysis of endobronchial ultrasound radiofrequency for the prediction of intrathoracic malignancy
Acronym
endobronchial ultrasound spectrum analysis for the prediction of malignancy
Scientific Title
Spectrum analysis of endobronchial ultrasound radiofrequency for the prediction of intrathoracic malignancy
Scientific Title:Acronym
endobronchial ultrasound spectrum analysis for the prediction of malignancy
Region
| Japan |
Condition
Condition
intrathoracic tumor including lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop the prediction system for intrathoracic malignant by analyzing endobronchail ultrasound radiofrequency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy by using the specific spectrum value (slope, mid-band fit, intercept) during endobronchial ultrasound.
Key secondary outcomes
Measurement of ultrasonic spectral parameters during endobronchial ultrasound.
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
Candidates for endobronchial ultrasonography.
Key exclusion criteria
Inability to give informed consent.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Nakajima |
Organization
Chiba University Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
takahiro_nakajima@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Nakajima |
Organization
Chiba University Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
takahiro_nakajima@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 04 | Month | 11 | 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
| 2016 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Measurement of ultrasonic spectral parameters during endobronchial ultrasound and prospectively recorded independently that blind to pathologists.
2. Compare the results between prediction by spectrum parameters and pathological diagnosis.
3. Analysis of sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of spectrum parameters.
Management information
Registered date
| 2017 | Year | 04 | Month | 10 | Day |
Last modified on
| 2018 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030897
