UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Study for training and evaluation of various computer-assisted detection (CAD) software (1st period)
Title of the study (Brief title)	Multicenter Study for training and evaluation of various computer-assisted detection (CAD) software (1st 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 September 2014. 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 October 2014 and 31 March 2015.
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	2000

Research contact person
Name of lead principal investigator	Naoto Hayashi
Organization	The University of Tokyo Hospital
Division name	Department of Computational Diagnostic Radiology and Preventive Medicine
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	Yukihiro Nomura
Organization	The University of Tokyo Hospital
Division name	Department of Computational Diagnostic Radiology and Preventive Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	2014 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 24 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://www.ut-radiology.umin.jp/ical/CIRCUS/events/201408_cadchallenge2014/results.html
Results
Other related information	multicenter, prospective observational study

Management information
Registered date	2014 Year 09 Month 24 Day
Last modified on	2016 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017718