UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter study on computer-aided detection from mammography using convolutional neural network
Acronym	KBOG1701 trial
Scientific Title	Multicenter study on computer-aided detection from mammography using convolutional neural network
Scientific Title:Acronym	KBOG1701 trial
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Computer-aided detection of mammography using deep learning
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy Sensitivity Specificity
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	biopsy-proven lesion, either benign or malignant apparently markable on mammography for multiple lesions, markable at each lesion
Key exclusion criteria	treated by neoadjuvant therapy treated by surgery breast tomosynthesis PET mammography mammography with severely low resolution
Target sample size	15000

Research contact person
Name of lead principal investigator	1st name Yutaka Middle name Last name Tokuda
Organization	Tokai University
Division name	Dept. of Endocrine & Breast Surgery
Zip code	259-1292
Address	4-1-1 Kitakaname, Hiratsuka, Kanagawa 259-1291
TEL	0463-58-1211
Email	tokuda@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	1st name Kenichi Middle name Last name Inoue
Organization	Shonan Memorial Hospital
Division name	Breast Cancer Center
Zip code	248-0027
Address	2-2-60 Fueda, Kamakura, Kanagawa 248-0027
TEL	0467-32-3456
Homepage URL
Email	kinoue@syonankinenhp.or.jp

Sponsor
Institute	Kanagawa Breast Oncology Group (KBOG)
Institute
Department

Funding Source
Organization	Kanagawa Breast Oncology Group (KBOG)
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	Shonan Memorial Hospital
Address	2-2-60 Fueda, Kamakura, Kanagawa 248-0027
Tel	0467-32-3456
Email	info@syonankinenhp.or.jp

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 11 Month 16 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	9
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	No longer recruiting
Date of protocol fixation	2017 Year 11 Month 02 Day
Date of IRB	2017 Year 11 Month 02 Day
Anticipated trial start date	2019 Year 06 Month 30 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Automatically cropped images from mammography are labeled whether breast cancer patterns are drawn. Images are used as input for the supervised learning using deep learning.

Management information
Registered date	2017 Year 11 Month 16 Day
Last modified on	2020 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034243