UMIN-CTR Clinical Trial

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 Fumio Middle name Last name Takada
Organization	Kitasato University Hospital
Division name	Genetics
Zip code	252-0375
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 Naomi Middle name Last name Araki
Organization	Kitasato University Hospital
Division name	Genetics
Zip code	252-0375
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa.
TEL	042-778-8111
Homepage URL
Email	arnaoe@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 Kitasato University Hospital, Breast and Endocrine Surgery
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board for Clinical Research and Treatment
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa.
Tel	042-778-8111
Email	rinrib@med.kitasato-u.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	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	2017 Year 08 Month 22 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2032 Year 03 Month 31 Day
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	2020 Year 09 Month 01 Day

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