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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021531
Receipt No. R000024769
Scientific Title A study on safety of risk reducing mastectomy(RRM)
Date of disclosure of the study information 2016/03/24
Last modified on 2019/04/25

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Basic information
Public title A study on safety of risk reducing mastectomy(RRM)
Acronym A study on safety of RRM
Scientific Title A study on safety of risk reducing mastectomy(RRM)
Scientific Title:Acronym A study on safety of RRM
Region
Japan

Condition
Condition Hereditary breast and ovarian cancer
Classification by specialty
Breast surgery Obsterics and gynecology Plastic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To confirm the safety of risk reducing mastectomy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Adverse event related to RRM during 3 months after RRM
Key secondary outcomes Adverse event related to RRM between 3 months and 5 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.BRCA1/2 mutation carriers
2.Woman with breast cancer in present or
the past
3.Woman who received genetic counseling
4.ECOG Performance Status=0
5.Informed consent
Key exclusion criteria 1.Woman with unstable mental state
2.Pregnant or lactating woman
3.Woman with active overlap cancer
4.The case in which doctor does not
approve to perform RRM.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiyo Yoshimura
Organization Aichi Cancer Center Hospital
Division name breast oncology
Zip code
Address 1-1.Kanokoden,Chikusa-ku,Nagoya
TEL 052-762-6111
Email akiyo@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiyo Yoshimura
Organization Aichi Cancer Center Hospital
Division name breast oncology
Zip code
Address 1-1.Kanokoden,Chikusa-ku,Nagoya
TEL 052-762-6111
Homepage URL
Email akiyo@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization Aichi Cancer Center 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
Address
Tel
Email

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 愛知県がんセンター中央病院 (Aichi Cancer Center Hospital) 

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2014 Year 04 Month 15 Day
Date of IRB
2014 Year 02 Month 21 Day
Anticipated trial start date
2014 Year 04 Month 24 Day
Last follow-up date
2021 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
2016 Year 03 Month 18 Day
Last modified on
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024769

Research Plan
Registered date File name
2017/03/20 研究実施計画書 .doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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