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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023606
Receipt No. R000027182
Scientific Title Evaluation of risk-reducing salpingo-oophorectomy for patients with BRCA 1/2 mutation
Date of disclosure of the study information 2016/08/12
Last modified on 2018/02/20

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Basic information
Public title Evaluation of risk-reducing salpingo-oophorectomy for patients with BRCA 1/2 mutation
Acronym Evaluation of RRSO for patients with BRCA 1/2 mutation
Scientific Title Evaluation of risk-reducing salpingo-oophorectomy for patients with BRCA 1/2 mutation
Scientific Title:Acronym Evaluation of RRSO for patients with BRCA 1/2 mutation
Region
Japan

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

Objectives
Narrative objectives1 establish system of RRSO
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)safety of RRSO
2)5year overall survival
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 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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria patients with deleterious familial mutation of BRCA 1/2
Key exclusion criteria no mutation of BRCA1/2
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Moriomi Matsumura
Organization Kindai University
Division name obstetrics and gynecology
Zip code
Address 377-1 Onohigashi Osakasayama Osaka Japan
TEL 072-366-0221
Email sanfu@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidekatsu Nakai
Organization Kindai University
Division name Obstetrics and gynecology
Zip code
Address 377-1 Onohigashi Osakasayama Osaka Japan
TEL 072-366-0221
Homepage URL
Email sanfu@med.kindai.ac.jp

Sponsor
Institute Kindai University
Institute
Department

Funding Source
Organization Kindai 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
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
2016 Year 08 Month 12 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
2016 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 12 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
2016 Year 08 Month 12 Day
Last modified on
2018 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027182

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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