UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy study of Risk-Reducing salpingo-oopholectomy in BRCA1/2 mutant carriers
Title of the study (Brief title)	Cohort Study of Risk Reducing Salpingo-oophlectomy in HBOC
Region	Japan

Condition
Condition	Hereditary Breast and Ovarian Cancer syndrome: HBOC
Classification by specialty	Surgery in general Endocrine surgery Breast surgery Obsterics and gynecology
Classification by malignancy	Malignancy
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse event related to RRSO
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Treatment
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. BRCA1/2 mutant carriers 2. Tolerability to RRSO 3. informed consent
Key exclusion criteria	1. Women with tubular or ovarian disease 2. physicians decision
Target sample size	20

Research contact person
Name of lead principal investigator	Keiichiro Nakamura
Organization	Okayama university hospital
Division name	Department of gynecology
Address	Shikata-cho 2-5-1, Okayama-city
TEL	086-235-7636
Email	k-nakamu@cc.okayama-u.ac.jp

Public contact
Name of contact person	Naruto Taira
Organization	Okayama University Hospital
Division name	Department of Breast and Endocrine Surgery
Address	Shikata-cho 2-5-1, Okayama-city
TEL	086-235-7265
Homepage URL
Email	ntaira@md.okayama-u.ac.jp

Sponsor
Institute	Okayama university hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Okayama university hospital
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 09 Month 30 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 01 Month 27 Day
Anticipated trial start date	2016 Year 04 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	2014 Year 09 Month 02 Day
Last modified on	2016 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017473