UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038061 |
|---|---|
| Receipt number | R000043378 |
| Scientific Title | Feasibility study of risk reducing mastectomy (RRM) for BRCA1/2 mutation carriers |
| Date of disclosure of the study information | 2019/09/19 |
| Last modified on | 2024/03/28 12:53:05 |
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Basic information
Public title
Feasibility study of risk reducing mastectomy (RRM) for BRCA1/2 mutation carriers
Acronym
Feasibility study of risk reducing mastectomy (RRM) for BRCA1/2 mutation carriers
Scientific Title
Feasibility study of risk reducing mastectomy (RRM) for BRCA1/2 mutation carriers
Scientific Title:Acronym
Feasibility study of risk reducing mastectomy (RRM) for BRCA1/2 mutation carriers
Region
| Japan |
Condition
Condition
Hereditary breast and ovarian cancer
Classification by specialty
| Breast surgery | Obstetrics and Gynecology | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the safety and the incidence of complications of RRM
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety of RRM for BRCA1/2 mutation carriers
Incidence of complications related to surgery
Key secondary outcomes
Incidence of occult breast cancer for RRM
Incidence of breast cancer during 2 years after RRM
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
risk reducing mastectomy
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
| Not applicable |
Gender
Female
Key inclusion criteria
1.Woman with breast cancer in the past
2.BRCA1/2 mutation carriers who received genetic counseling
3.ECOG Performance Status=0, 1
4.Informed consent
Key exclusion criteria
1.The case in which doctor does not approve to perform RRM
2.Pregnant woman or woman with a possibility of pregnant
3.Doctor's decision not to be registered to this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Ogawa |
Organization
Mie University Hospital
Division name
breast center
Zip code
5148507
Address
2-174, Edobashi, Tsu, Mie
TEL
0592321111
mokomoko@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Mao |
| Middle name | |
| Last name | Kimoto |
Organization
Mie University Hospital
Division name
breast center
Zip code
5148507
Address
2-174, Edobashi, Tsu, Mie
TEL
0592321111
Homepage URL
murata-c@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Donation for research
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
Mie University Hospital Institutional Review Board
Address
2-174, Edobashi, Tsu, Mie
Tel
0592321111
////
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
| 2019 | Year | 09 | Month | 19 | 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
0
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
Terminated
Date of protocol fixation
| 2019 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2019 | Year | 09 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043378
| 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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