UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037538 |
|---|---|
| Receipt number | 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 | 2023/08/02 09:40:08 |
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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
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
takayuki.ueno@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital
Department of Breast surgery
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
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
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042760
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
