UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050748 |
|---|---|
| Receipt number | R000057822 |
| Scientific Title | Effects of mammographic density on post-menopausal breast cancer risk: a cohort study using a breast density analysis software program (Bda) |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/04/02 13:21:10 |
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Basic information
Public title
Effects of mammographic density on post-menopausal breast cancer risk: a cohort study using a breast density analysis software program
Acronym
Effects of mammographic density on post-menopausal breast cancer risk
Scientific Title
Effects of mammographic density on post-menopausal breast cancer risk: a cohort study using a breast density analysis software program (Bda)
Scientific Title:Acronym
Effects of mammographic density on post-menopausal breast cancer risk: a cohort study using a breast density analysis software program
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effects of mammographic density on post-meanopausal breast cancer risk using a breast density analysis software program (Bda)
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Effects of mammographic density on post-menopausal breast cancer risk using a breast density analysis software program (Bda)
Key secondary outcomes
A relationship between mammographic density and lifestyle survey items such as age, body mass index, familial history of breast cancer
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
Female
Key inclusion criteria
Post-menopausal women examined with mammography in 2018-2022.
Key exclusion criteria
not applicable
Target sample size
3200
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Tokuda |
Organization
Seirei Yokohama Hospital
Division name
Breast Center
Zip code
240-8521
Address
215 Iwai-chyo, Hodogaya-ku, Yokohama, Kanagawa 240-8521, Japan
TEL
045-715-3111
y-tokuda@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Tokuda |
Organization
Seirei Yokohama Hospital
Division name
Breast Center
Zip code
240-8521
Address
215 Iwai-chyo, Hodogaya-ku, Yokohama, Kanagawa 240-8521, Japan
TEL
045-715-3111
Homepage URL
y-tokuda@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Yokohama Hospital
Address
215 Iwai-chyo,Hodogaya-ku, Yokohama, Kanagawa 240-8521, Japan
Tel
045-715-3111
y-tokuda@sis.seirei.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
聖隷横浜病院(神奈川県)／ Seirei Yokohama Hospital (Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2023 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2023 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057822
| 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 |
