UMIN-CTR Clinical Trial

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

Condition
Condition	BRCA1/2 mutant carriers
Classification by specialty	Surgery in general Endocrine surgery Breast surgery Obsterics and gynecology Operative medicine
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 mutant 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	3

Research contact person
Name of lead principal investigator	Taisuke Mori
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Obstetrics and Gynecology
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
TEL	075-251-5560
Email	moriman@koto.kpu-m.ac.jp

Public contact
Name of contact person	Taisuke Mori
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Obstetrics and Gynecology
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
TEL	075-251-5560
Homepage URL
Email	moriman@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University 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 09 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 31 Day
Anticipated trial start date	2017 Year 09 Month 01 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 06 Month 12 Day
Last modified on	2017 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031764