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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029303
Receipt No. R000033499
Scientific Title Feasibility study of risk reducing mastectomy for women with BRCA1/2 mutations.
Date of disclosure of the study information 2017/09/27
Last modified on 2017/09/27

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Basic information
Public title Feasibility study of risk reducing mastectomy for women with BRCA1/2 mutations.
Acronym Feasibility study of risk reducing mastectomy for women with BRCA1/2 mutations.
Scientific Title Feasibility study of risk reducing mastectomy for women with BRCA1/2 mutations.
Scientific Title:Acronym Feasibility study of risk reducing mastectomy for women with BRCA1/2 mutations.
Region
Japan

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

Objectives
Narrative objectives1 To confirm the safety and to assess the feasibility of Risk Reducing Mastectomy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Adverse events within 1 year aftr surgery
Key secondary outcomes the rate of occult cancer
the rate of locoregional recurrence
Adverse events within 5 year aftr 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 mastectomy
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 females 20 years or older
after receiving genetic counseling in our institution
with BRCA1 or 2 mutation
without recurrence and distant metastasis
desire for risk reducing mastectomy
ECOG performance status 0
Key exclusion criteria with other active primary cancer
inappropriate mental condition
pregnant or nursing
severe infection
physician judged in appropriateness
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiyo Yoshimura
Organization Aichi Cancer Center Hospital, Nagoya, Japan
Division name Department of Breast Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL 052-762-6111
Email akiyo@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiyo Yoshimura
Organization Aichi Cancer Center Hospital, Nagoya, Japan
Division name Department of Breast Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL 052-762-6111
Homepage URL
Email akiyo@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital, Nagoya, Japan
Institute
Department

Funding Source
Organization Aichi Cancer Center Hospital, Nagoya, Japan
Organization
Division
Category of Funding Organization Other
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 27 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
2017 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 22 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 09 Month 27 Day
Last modified on
2017 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033499

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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