UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk-Reducing salpingo-oopholectomy in BRCA1/2 mutant carriers
Title of the study (Brief title)	Risk-Reducing salpingo-oopholectomy in BRCA1/2 mutant carriers
Region	Japan

Condition
Condition	BRCA1/2 mutant carriers
Classification by specialty	Surgery in general Breast surgery Obsterics and gynecology Operative medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of risk reducing salpingo-oophorectomy (RRSO) in BRCA1/2 mutnat carriers
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The safety and efficacy of risk reducing salpingo-oophorectomy (RRSO) in BRCA1/2 mutnat carriers
Key secondary outcomes

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 salpingo-oophorectomy (RRSO)
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)BRCA1/2 mutant carriers 2)prefer not to pregnant women 3)Performance Status: 0-1 4)informed consent
Key exclusion criteria	pregnant woman or possibility for pregnant women
Target sample size	5

Research contact person
Name of lead principal investigator	Eiji Kondo
Organization	Mie university faculty of Medicine
Division name	Department of Obstetrics and Gynecology
Address	2-174, Edobashi, Tsu city, Mie, Japan
TEL	059-232-1111
Email	eijikon@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Eiji Kondo
Organization	Mie University School of Medicine
Division name	Department of Obstetrics and Gynecology
Address	2-174, Edobashi, Tsu city, Mie, Japan
TEL	059-232-1111
Homepage URL
Email	eijikon@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie university faculty of Medicine
Institute
Department

Funding Source
Organization	Mie university faculty of Medicine
Organization
Division
Category of Funding Organization	Other
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 03 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 24 Day
Anticipated trial start date	2017 Year 03 Month 20 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 02 Month 24 Day
Last modified on	2018 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030206