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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037538
Receipt No. R000042760
Scientific Title Development of three-dimensional prediction system of breast morphology in breast conserving surgery
Date of disclosure of the study information 2019/10/01
Last modified on 2021/02/01

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Basic information
Public title Development of a system to predict breast shape after breast conserving surgery using artificial intelligence
Acronym Development of a system to predict breast shape after breast conserving surgery using artificial intelligence
Scientific Title Development of three-dimensional prediction system of breast morphology in breast conserving surgery
Scientific Title:Acronym Development of three-dimensional prediction system of breast morphology in breast conserving surgery
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to construct a system to predict post-operative breast morphology from one prior to breast-conserving surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Study1:Construction of breast morphology prediction system after breast conserving surgery and identification of predictors affecting breast morphology.
Study2:Verification of the key prediction factors that affect the breast morphology and the accuracy of the prediction system built in Study 1.
Key secondary outcomes Verification of the effect on postoperative breast morphology by radiation therapy and reconstruction method.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Study1: A patient who underwent breast concerving surgery for primary breast cancer at the Cancer Institute Hospital from January 2009 to June 2016.
Study2: A patient who underwent breast concerving surgery for primary breast cancer at the Cancer Institute Hospitalfrom January 2020 to December 2022.
Key exclusion criteria 1) Persons who have refused to participate in this study.
2) male
3) Cases in which the attending physician judged that participation in this study was inappropriate.
4) Under 18 years old.
5) Cases who are naturally have unilateral hypoplasia consequently marked asymmetory in breast.
6) Bilateral breast cancer
7) Those who have had any breast surgery history (beyond excision biopsy).
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Ueno
Organization Cancer Institute Hospital
Division name Breast surgery
Zip code 135-8550
Address 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL 03-3520-0111
Email takayuki.ueno@jfcr.or.jp

Public contact
Name of contact person
1st name Takayuki
Middle name
Last name Ueno
Organization Cancer Institute Hospital
Division name Breast Surgery
Zip code 135-8550
Address 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL 03-3520-0111
Homepage URL
Email takayuki.ueno@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital
Department of Breast surgery
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Cancer Institute Hospital
Address 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
Tel 03-3520-0111
Email takayuki.ueno@jfcr.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 がん研究会有明病院

Other administrative information
Date of disclosure of the study information
2019 Year 10 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 100
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Study 1: Case registration has been completed, but data analysis and system construction have been delayed due to the spread of Covid19 infection.
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 Preinitiation
Date of protocol fixation
2019 Year 07 Month 30 Day
Date of IRB
2019 Year 10 Month 10 Day
Anticipated trial start date
2019 Year 11 Month 13 Day
Last follow-up date
2022 Year 12 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Joint research institute
Osaka University Graduate School of Dentistry
Chihiro Tanikawa

Management information
Registered date
2019 Year 07 Month 30 Day
Last modified on
2021 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042760

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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