UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015240
Receipt number R000017718
Scientific Title Multicenter Study for training and evaluation of various computer-assisted detection (CAD) software (1st period)
Date of disclosure of the study information 2014/10/01
Last modified on 2016/06/20 10:45:49

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Basic information

Public title

Multicenter Study for training and evaluation of various computer-assisted detection (CAD) software (1st period)

Acronym

Multicenter Study for training and evaluation of various computer-assisted detection (CAD) software (1st period)

Scientific Title

Multicenter Study for training and evaluation of various computer-assisted detection (CAD) software (1st period)

Scientific Title:Acronym

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



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 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

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 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


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

2014 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://www.ut-radiology.umin.jp/ical/CIRCUS/events/201408_cadchallenge2014/results.html

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

2014 Year 09 Month 24 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017718


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name