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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020648
Receipt No. R000022475
Scientific Title Study of risk reducing bilateral salpingo-oophorectomy (RRSO) for japanese BRCA1/2 mutation carriers
Date of disclosure of the study information 2016/01/20
Last modified on 2020/07/27

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Basic information
Public title Study of risk reducing bilateral salpingo-oophorectomy (RRSO) for japanese BRCA1/2 mutation carriers
Acronym Study of RRSO for BRCA1/2 mutation carriers
Scientific Title Study of risk reducing bilateral salpingo-oophorectomy (RRSO) for japanese BRCA1/2 mutation carriers
Scientific Title:Acronym Study of RRSO for BRCA1/2 mutation carriers
Region
Japan

Condition
Condition hereditary breast and ovarian cancer
Classification by specialty
Breast surgery Obsterics and gynecology Adult
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of risk reducing salpingo-oophorectomy in BRCA1/2 mutant carriers
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incidence and mortality rate of the ovarian/fallopian tube/peritoneal cancer on BRCA1/2 mutant carriers performed risk reducing salpingo-oophorectomy every year
Key secondary outcomes Adverse event related to RRSO

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
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

Not applicable
Gender Female
Key inclusion criteria 1.BRCA1/2 mutant carriers
2.Informed consent
3.Women who can visit our hospital to an annual follow-up survey after the surgery
Key exclusion criteria 1.Intlerability to RRSO for other disease
2.Women with ovarian or tubal cancer
3.Women with other ovarian disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yashisa
Middle name
Last name Terao
Organization Juntendo University
Division name Department of Obstetrics and Gynecology
Zip code 1138421
Address 2-1-1 Hongo, Bunkyo-ku Tokyo
TEL 03-5802-1100
Email yterao@juntendo.ac.jp

Public contact
Name of contact person
1st name Yasuhisa
Middle name
Last name Terao
Organization Juntendo University
Division name Department of Obstetrics and Gynecology
Zip code 1138421
Address 2-1-1 Hongo, Bunkyo-ku Tokyo
TEL 03-5802-1100
Homepage URL
Email yterao@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University
Address 2-1-1 Hongo, Bunkyo-ku Tokyo
Tel 03-3813-3111
Email kenkyu5858@juntendo.ac.jp

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
2016 Year 01 Month 20 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 Open public recruiting
Date of protocol fixation
2015 Year 10 Month 21 Day
Date of IRB
2016 Year 01 Month 21 Day
Anticipated trial start date
2016 Year 01 Month 21 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 20 Day
Last modified on
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022475

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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