UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048349 |
|---|---|
| Receipt number | R000055106 |
| Scientific Title | A retrospective study on the evaluation of dense breast in digital mammograms for breast cancer screening |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2023/02/02 13:15:24 |
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Basic information
Public title
A retrospective study on the evaluation of dense breast in digital mammograms for breast cancer screening
Acronym
A retrospective study on the evaluation of dense breast in digital mammograms for breast cancer screening
Scientific Title
A retrospective study on the evaluation of dense breast in digital mammograms for breast cancer screening
Scientific Title:Acronym
A retrospective study on the evaluation of dense breast in digital mammograms for breast cancer screening
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to estimate the breast density of Japanese women objectively in digital mammograms for breast cancer screening using a fully automated breast density assessment software (Volpara Density)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Distribution of dense breasts by age using Volpara Density
Key secondary outcomes
Effect of dense breasts to cancer screening
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
Patients undergoing mammography for breast cancer screening
Key exclusion criteria
Patients who investigators do not consider to be eligible for this study
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kubo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka City, 812-8582, Japan
TEL
092-642-5440
Kubo.makoto.804@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Kubo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka City, 812-8582, Japan
TEL
092-642-5440
Homepage URL
Kubo.makoto.804@m.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toshiharu Mori,
Breast Diagnostic Center Serenade, Wellness Tenjin, Medical Treatment Corporate Foundantion HAKUAIKAI
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Ethical Review Committe
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka City, Japan
Tel
092-642-6254
ijkseimei@jimu.kyushu-u.ac.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
| 2022 | Year | 07 | Month | 12 | 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
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
| 2021 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055106
