UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039736 |
|---|---|
| Receipt number | R000045319 |
| Scientific Title | Breast screening combined with non-enhanced breast MRI and breast automatic ultrasound. |
| Date of disclosure of the study information | 2020/03/08 |
| Last modified on | 2020/09/07 14:46:19 |
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Basic information
Public title
Breast screening combined with non-enhanced breast MRI and breast automatic ultrasound.
Acronym
Breast screening combined with non-enhanced breast MRI and breast automatic ultrasound.
Scientific Title
Breast screening combined with non-enhanced breast MRI and breast automatic ultrasound.
Scientific Title:Acronym
Breast screening combined with non-enhanced breast MRI and breast automatic ultrasound.
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of the usefulness of non-enhanced MRI in screening for breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination of non-contrast MRI findings in breast cancer screening.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Comparison of Breast Ultrasound and Non-contrast MRI Findings in Single Breast Screening.
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
Documented consent to test plan.
Women who are not pregnant or nursing.
Currently working at this facility.
Key exclusion criteria
Pregnant or breastfeeding.
When judged to be inappropriate for participation in this test.
Not working at this facility.
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Shinsaku |
| Middle name | |
| Last name | KANAZAWA |
Organization
SUNKOKAI social medical corporation KOGA Hospital
Division name
Breast Surgery
Zip code
425-0088
Address
2-30-1, Daikakuji, Yaizu-shi, Shizuoka
TEL
0546285500
shikanazawa-gi@umin.net
Public contact
Name of contact person
| 1st name | Shinsaku |
| Middle name | |
| Last name | KANAZAWA |
Organization
SUNKOKAI social medical corporation KOGA Hospital
Division name
Breast Surgery
Zip code
425-0088
Address
2-30-1, Daikakuji, Yaizu-shi, Shizuoka
TEL
0546285500
Homepage URL
shikanazawa-gi@umin.net
Sponsor or person
Institute
SYUNKOKAI social medical corporation KOGA Hospital
Institute
Department
Personal name
Funding Source
Organization
SUNKOKAI social medical corporation KOGA Hospital
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
SUNKOKAI social medical corporation KOGA Hospital
Address
2-30-1, Daikakuji, Yaizu-shi, Shizuoka
Tel
0546285500
shikanazawa-gi@umin.net
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
| 2020 | Year | 03 | Month | 08 | 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
45
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
| 2020 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 08 | Day |
Last modified on
| 2020 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045319
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
