UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026509
Receipt number 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 14:20:43

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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 or person

Institute

Cancer Institute Hospital
department of clinical genetic oncology, breast center

Institute

Department

Personal name



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

Value
https://center6.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