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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030431
Receipt No. R000034746
Scientific Title Feasibility and effecacy of risk-reducing surgery for BRCA1/2 deleterious mutation carriers
Date of disclosure of the study information 2017/12/18
Last modified on 2017/12/16

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Basic information
Public title Feasibility and effecacy of risk-reducing surgery for BRCA1/2 deleterious mutation carriers
Acronym Risk-reducing surgery for BRCA1/2 deleterious mutation carriers
Scientific Title Feasibility and effecacy of risk-reducing surgery for BRCA1/2 deleterious mutation carriers
Scientific Title:Acronym Risk-reducing surgery for BRCA1/2 deleterious mutation carriers
Region
Japan

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

Objectives
Narrative objectives1 To confirm feasibility of risk-reducing salpingo-oophorectomy and risk-reducing mastectomy with breast reconstruction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency of surgical complications
Key secondary outcomes Preventive efficacy of breast and ovarian cancer

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
Other
Interventions/Control_1 Risk-reducing salpingo-oophorectomy
Risk-reducing mastectomy with breast reconstruction
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
70 years-old >
Gender Female
Key inclusion criteria Carriers of deleterious mutation of BRCA1 or BRCA2
Key exclusion criteria Non-carriers of deleterious mutation of BRCA1 or BRCA2
Patients who has not received genetic testing for BRCA1 or BRCA2
Carriers who dose not hope to receive risk-reducing surgery
Carriers who dose not give her consent for risk-reducing surgery
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Tamaki
Organization Osaka International Cancer Institute
Division name Breast and endocrine surgery
Zip code
Address 3-1-69, Otemae, Tyuo-ku, Osaka
TEL 06-6945-1181
Email tamaki-ya@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Tamaki
Organization Osaka International Cancer Institute
Division name Breast and endocrine surgery
Zip code
Address 3-1-69, Otemae, Tyuo-ku, Osaka
TEL 06-6945-1181
Homepage URL
Email tamaki-ya@mc.pref.osaka.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization The Osaka Foundation for The Prevention of Cancer and Life-style related Diseases
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 18 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 Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 16 Day
Last modified on
2017 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034746

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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