UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility and effecacy of risk-reducing surgery for BRCA1/2 deleterious mutation carriers
Title of the study (Brief title)	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	Yasuhiro Tamaki
Organization	Osaka International Cancer Institute
Division name	Breast and endocrine surgery
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	Yasuhiro Tamaki
Organization	Osaka International Cancer Institute
Division name	Breast and endocrine surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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