UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017981 |
|---|---|
| Receipt number | R000020835 |
| Scientific Title | Multicenter study for training and evaluation of various computer-assisted detection (CAD) software (2nd period) |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2017/06/20 09:57:06 |
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Basic information
Public title
Multicenter study for training and evaluation of various computer-assisted detection (CAD) software (2nd period)
Acronym
Multicenter study for training and evaluation of various computer-assisted detection (CAD) software (2nd period)
Scientific Title
Multicenter study for training and evaluation of various computer-assisted detection (CAD) software (2nd period)
Scientific Title:Acronym
Multicenter study for training and evaluation of various computer-assisted detection (CAD) software (2nd period)
Region
| Japan |
Condition
Condition
cerebral aneurysm
lung nodule
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To run machine learning and to evaluate the efficiency on large clinical datasets of the University of Tokyo Hospital, for CAD software developed in other institutions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection performance of CAD software
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Positive cases of chest CT or head MRA screening before 30 June 2015.
Chest CT: at least one lung nodule of 5mm or more.
Head MRA: at least one cerebral aneurysm of 2mm or more.
2) Chest CT or head MRA screening cases between 1 July 2015 and 31 March 2016.
Key exclusion criteria
1) multiple lung nodules (more than 5 nodules)
2) difficult to distinguish between lung nodule and pneumonia
3) inappropriate cases for this study judged by two radiologists
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Hayashi |
Organization
The University of Tokyo Hospital
Division name
Department of Computational Diagnostic Radiology and Preventive Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
TEL
03-5800-8666
naoto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Nomura |
Organization
The University of Tokyo Hospital
Division name
Department of Computational Diagnostic Radiology and Preventive Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
TEL
03-5800-8666
Homepage URL
nomuray-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multicenter, prospective observational study
Management information
Registered date
| 2015 | Year | 06 | Month | 19 | Day |
Last modified on
| 2017 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020835
| Research Plan | |
|---|---|
| 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 |
