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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036134
Receipt No. R000041167
Scientific Title A Safety evaluation of risk-reducing mastectomy for BRCA1/2 pathological variant carriers
Date of disclosure of the study information 2019/06/01
Last modified on 2019/03/08

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Basic information
Public title A Safety evaluation of risk-reducing mastectomy for BRCA1/2 pathological variant carriers
Acronym A Safety evaluation of RRM for BRCA1/2 pathological variant carriers
Scientific Title A Safety evaluation of risk-reducing mastectomy for BRCA1/2 pathological variant carriers
Scientific Title:Acronym A Safety evaluation of RRM for BRCA1/2 pathological variant carriers
Region
Japan

Condition
Condition BRCA1/2 pathological variant carriers
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore safety of risk-reducing mastectomy for BRCA1/2 pathological variant carriers
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety of risk-reducing mastectomy
Key secondary outcomes 1)Incidence of breast cancer after risk-reducing mastectomy
2)Incidence of complications related risk-reducing mastectomy
3)Incidence of occult breast cancer and precancerous lesions

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Surgery : 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 1)BRCA1/2 pathological variant carriers
2)Woman without ipsilateral breast cancer occurrence
3)Woman who can visit our hospital to a follow-up survey after surgery
4)Informed consent
Key exclusion criteria 1)Pregnant woman or possibility for pregnant woman

2)Physicaians concludes that the patient participation on this study in inappropriate.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoharu Sugie
Organization Kansai medical university hospital
Division name Department of surgery
Zip code
Address 2-3-1 Shinmachi, Hirakata, Osaka
TEL 072-804-0101
Email sugiet@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu Yanai
Organization Kansai medical university hospital
Division name Department of surgery
Zip code
Address 2-3-1 Shinmachi, Hirakata, Osaka
TEL 072-804-0101
Homepage URL
Email yanaih@hirakata.kmu.ac.jp

Sponsor
Institute Kansai medical university hospital
Institute
Department

Funding Source
Organization Kansai medical university
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
2019 Year 06 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 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

Management information
Registered date
2019 Year 03 Month 08 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041167

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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