UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053686 |
|---|---|
| Receipt number | R000061266 |
| Scientific Title | Role of ultrasonography in mammary gland health check |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/02/22 16:22:42 |
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Basic information
Public title
Role of ultrasonography in mammary gland health check
Acronym
Role of ultrasonography in mammary gland health check
Scientific Title
Role of ultrasonography in mammary gland health check
Scientific Title:Acronym
Role of ultrasonography in mammary gland health check
Region
| Japan |
Condition
Condition
mammary cancer
Classification by specialty
| Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is well known that mammography is uniquely suited to detect mammary cancer. In Japan, however, dense breast is rather common under 60 y/o women, providing the problem in detecting mammary cancer. Ohchi et al reported that the sensitivity to detect mammary cancer among 40-49 y/o Japanese women was improved by adding ultrasonography to mammography (Lancet. 2016 Jan 23;387(10016):341-348). We analyzes the efficacy of ultrasonography in detecting mammary cancer in the group other than 40-49 y/o.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Among various ages, the frequency of abnormal findings is compared between mammograph and ultrasonography in cases of mammary cancer.
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Female persons who visited our clinic for health check from 2020 to 2022, and who received mammography and/or ultrasonography
Key exclusion criteria
During pregnancy
persons who have been already diagnosed as mammary cancer.
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | TSUNEO |
| Middle name | |
| Last name | TAKENAKA |
Organization
Sanno Medical Center
Division name
Medicine
Zip code
107-0052
Address
8-5-35 Akasaka Minato Tokyo
TEL
03-3402-5581
takenaka@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | TSUNEO |
| Middle name | |
| Last name | TAKENAKA |
Organization
Sanno Medical Center
Division name
Medicine
Zip code
107-0052
Address
8-5-35 Akasaka Minato Tokyo
TEL
03-3402-5581
Homepage URL
takenaka@iuhw.ac.jp
Sponsor or person
Institute
Sanno Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sanno Medical Center
Address
8-5-35 Akasaka Minato Tokyo
Tel
03-3402-5581
takenaka@iuhw.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
| 2024 | Year | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
obsevational study
Management information
Registered date
| 2024 | Year | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061266
