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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027999
Receipt No. R000031743
Scientific Title Risk reducing salpingo-oophorectomy RRSO in BRCA1/2 mutation carriers.
Date of disclosure of the study information 2017/09/01
Last modified on 2018/07/02

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Basic information
Public title Risk reducing salpingo-oophorectomy RRSO in BRCA1/2 mutation carriers.
Acronym Risk reducing salpingo-oophorectomy RRSO in BRCA1/2 mutation carriers.
Scientific Title Risk reducing salpingo-oophorectomy RRSO in BRCA1/2 mutation carriers.
Scientific Title:Acronym Risk reducing salpingo-oophorectomy RRSO in BRCA1/2 mutation carriers.
Region
Japan

Condition
Condition Hereditary Breast and Ovarian Cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Women with a BRCA1/2 mutation or members of a hereditary breast ovarian cancer family (HBOC) have an increased risk of developing ovarian cancer. The only effective strategy to reduce this risk is a risk reducing salpingo-oophorectomy (RRSO). The aim of this study was to evaluate the short-term surgical outcome and safety of a RRSO.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The main outcome measure is the complication rate at 4 to 6 days and at 5 weeks after surgery, as indicator of safety of the surgical procedure.
Key secondary outcomes Secondary outcomes are to evaluate the appearance of menopausal symptoms rate before the surgery and at 6 and 24 months after the surgery

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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Having a deleterious mutation of BRCA1/2 germline gene
Key exclusion criteria Female has active invasive cancer.
Female with mental disabilities and who has difficulty to make a determination of therapy.
Female during pregnancy and lactation.
Femele with active infectional disease.
Female who a doctor consider inappropriate
Female under 20 years old
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kikkawa Fumitaka
Organization Nagoya university faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 65, Tsurumacho, Showa ku, Nagoya city, Aichi, Japan
TEL 052-744-2261
Email kikkawaf@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Utsumi Fumi
Organization Nagoya university faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 65, Tsurumacho, Showa ku, Nagoya city, Aichi, Japan
TEL 052-744-2261
Homepage URL
Email fufumifu@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya university faculty of Medicine
Institute
Department

Funding Source
Organization Nagoya university faculty of Medicine
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
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2017 Year 06 Month 19 Day
Date of IRB
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

Other
Other related information

Management information
Registered date
2017 Year 06 Month 29 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031743

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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