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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017981
Receipt No. 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

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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
Email 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
Email nomuray-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020835

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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