UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031603 |
|---|---|
| Receipt number | R000036080 |
| Scientific Title | Study of risk reducing contralateral mastectomy (RRM) for Japanese BRCA1/2 mutation carriers |
| Date of disclosure of the study information | 2018/03/06 |
| Last modified on | 2020/11/02 15:45:35 |
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Basic information
Public title
Study of risk reducing contralateral mastectomy (RRM) for Japanese BRCA1/2 mutation carriers
Acronym
Study of RRM for BRCA1/2 mutation carries
Scientific Title
Study of risk reducing contralateral mastectomy (RRM) for Japanese BRCA1/2 mutation carriers
Scientific Title:Acronym
Study of RRM for BRCA1/2 mutation carries
Region
| Japan |
Condition
Condition
hereditary breast and ovarian cancer
Classification by specialty
| Breast surgery | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluation the efficacy of risk reducing contralateral mastectomy in BRCA1/2 mutation carrier
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence and mortality rate of the breast cancer on BRCA1/2 mutation carrier performed risk reduction contralateral mastectomy
Key secondary outcomes
Adverse event related to 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 contralateral 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Breast cancer patient with BRCA1/2 mutation
2.Informed consent
3.Women who can visit our hospital to take follw-up survey after RRM
Key exclusion criteria
1.Intrelance to RRM for other disease
2.Women with breast cancer of contralateral breast
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsue Saito |
Organization
Juntendo University
Division name
Department of Breast Oncology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku Tokyo
TEL
03-3813-3111
mitsue@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsue Saito |
Organization
Juntendo University
Division name
Department of Breast Oncology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku Tokyo
TEL
03-3813-3111
Homepage URL
mitsue@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 03 | Month | 06 | 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
| 2017 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2018 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036080
