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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028849
Receipt No. R000033018
Scientific Title Feasibility study of Risk Reducing Mastectomy and Risk Reducing Salpingo-Oophorectomy for Hereditary Breast and Ovarian Cancer
Date of disclosure of the study information 2017/10/01
Last modified on 2018/04/13

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Basic information
Public title Feasibility study of Risk Reducing Mastectomy and Risk Reducing Salpingo-Oophorectomy for Hereditary Breast and Ovarian Cancer
Acronym Feasibility study of RRM and RRSO for HBOC
Scientific Title Feasibility study of Risk Reducing Mastectomy and Risk Reducing Salpingo-Oophorectomy for Hereditary Breast and Ovarian Cancer
Scientific Title:Acronym Feasibility study of RRM and RRSO for HBOC
Region
Japan

Condition
Condition HBOC
Classification by specialty
Breast surgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Safety assessment of RRM and RRSO For HBOC
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1Safety of surgery 2Prognosis 3QOL after surgery 4Complication of surgery 5Pathological data
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Genetic testing has confirmed a mutation in BRCA 1/2, and the individual desires RRM/RRSO after genetic counseling.
2) It is desirable person who have children, or understand that fertility is lost after this treatment with Husband, or does not wish to have baby, or have willing RRSO priority than wish to have baby.
3) Fully understanding the symptoms after RRM/RRSO.
4) Fully understanding that RRM/RRSO is self-pay.
5) Fully understanding that RRM/RRSO is clinical trial.
6) The person who choose RRM/RRSO does not have malignacy of breast and ovary.
Key exclusion criteria doctor's decision not to be registered to this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumio Takada
Organization Kitasato University Hospital
Division name Genetics
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa.
TEL 042-778-8111
Email ftakada@kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimasa Kosaka
Organization Kitasato University Hospital
Division name Breast and Endocrine Surgery
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa.
TEL 042-778-8111
Homepage URL
Email y-kosaka@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kitasato University Hospital, Gynecology
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 10 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 10 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 Safety assessment of RRM and RRSO For HBOC

Management information
Registered date
2017 Year 08 Month 27 Day
Last modified on
2018 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033018

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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