UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Breast Cancer Surveillance in Japanese BRCA1/2 Mutation Carriers
Title of the study (Brief title)	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	Masami Arai, Satoko Shimada
Organization	Cancer Institute Hospital
Division name	clinical genetic oncology
Address	3-8-31, Ariake, koto-ku, Tokyo
TEL	03-3520-0111
Email	marai@jfcr.or.jp

Public contact
Name of contact person	Masami Arai, Satoko Shimada
Organization	Cancer Institute Hospital
Division name	clinical genetic oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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