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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033384
Receipt No. R000038011
Scientific Title Feasibility study of risk reducing salpingo-oophorectomy for BRCA1/2 mutation carrier
Date of disclosure of the study information 2018/07/17
Last modified on 2018/07/13

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Basic information
Public title Feasibility study of risk reducing salpingo-oophorectomy for BRCA1/2 mutation carrier
Acronym RRSO for BRCA1/2 mutation carrier
Scientific Title Feasibility study of risk reducing salpingo-oophorectomy for BRCA1/2 mutation carrier
Scientific Title:Acronym RRSO for BRCA1/2 mutation carrier
Region
Japan

Condition
Condition Hereditary breast ovarian cancer syndrome
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the feasibility of risk reducing salpingo-oophorectomy for BRCA mutation carrier
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Rate of adverse event intra- or after operation
Key secondary outcomes Rate of operation associated death
Incidence of of occult cancer

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 risk reducing sapling-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
30 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.BRCA mutant carrier
2.no prior ovarian cancer
3.wish for operation after counseling
4.no wish for pregnancy
5.over 35 years old

Key exclusion criteria no mutation of BRCA
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Sugino
Organization Yamaguchi University
Division name Obstetrics and Gynecology
Zip code
Address 1-1-1 Minami-kogushi Ube, Japan
TEL 0836-22-2288
Email obgyn@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Sueoka
Organization Yamaguchi University
Division name Obstetrics and Gynecology
Zip code
Address 1-1-1 Minami-kogushi Ube, Japan
TEL 0836-22-2288
Homepage URL
Email obgyn@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Hospital
Institute
Department

Funding Source
Organization Yamaguchi 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 山口大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 17 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2026 Year 03 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
2018 Year 07 Month 13 Day
Last modified on
2018 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038011

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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