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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026509
Receipt No. R000030407
Scientific Title Efficacy of Breast Cancer Surveillance in Japanese BRCA1/2 Mutation Carriers
Date of disclosure of the study information 2017/03/13
Last modified on 2017/03/11

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Basic information
Public title Efficacy of Breast Cancer Surveillance in Japanese BRCA1/2 Mutation Carriers
Acronym Breast Cancer Surveillance in Japanese BRCA1/2 Mutation Carriers
Scientific Title Efficacy of Breast Cancer Surveillance in Japanese BRCA1/2 Mutation Carriers
Scientific Title:Acronym Breast Cancer Surveillance in Japanese BRCA1/2 Mutation Carriers
Region
Japan

Condition
Condition BRCA1/2 Mutation Carriers
Classification by specialty
Breast surgery Laboratory medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To determine the clinical benefits of surveillance with half-yearly ultrasonography, clinical breast examination (CBE), annual mammography, and magnetic resonance imaging (MRI) in the early detection of breast cancer in Japanese BRCA1/2 Mutation Carriers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We investigated the distinct roles of mammography, ultrasonography, MRI, and CBE for the detection of breast cancer in women with BRCA1/2 mutations. The medical records of participants who were confirmed to have BRCA1/2 mutations during genetic counseling between January 1, 2000 and October 31, 2016 were reviewed.
Key secondary outcomes

Base
Study type Observational

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria BRCA1/2 mutation carriers
Key exclusion criteria The individuals who do not wish to participate to this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masami Arai, Satoko Shimada
Organization Cancer Institute Hospital
Division name clinical genetic oncology
Zip code
Address 3-8-31, Ariake, koto-ku, Tokyo
TEL 03-3520-0111
Email marai@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masami Arai, Satoko Shimada
Organization Cancer Institute Hospital
Division name clinical genetic oncology
Zip code
Address 3-8-31, Ariake, koto-ku, Tokyo
TEL 03-3520-0111
Homepage URL
Email marai@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital
department of clinical genetic oncology, breast center
Institute
Department

Funding Source
Organization None
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 03 Month 13 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 Completed
Date of protocol fixation
2016 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study was to determine the clinical benefits of surveillance in BRCA1/2 mutation carriers with half-yearly ultrasonography, CBE, annual mammography, and MRI in the early detection of breast cancer.

Management information
Registered date
2017 Year 03 Month 11 Day
Last modified on
2017 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030407

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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