UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013764
Receipt number R000016064
Scientific Title The preventing treatment of the breast cancer high risk case( the gene mutation positive case )
Date of disclosure of the study information 2014/05/01
Last modified on 2014/04/19 15:27:14

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Basic information

Public title

The preventing treatment of the breast cancer high risk case( the gene mutation positive case )

Acronym

The preventing treatment of the breast cancer high risk case

Scientific Title

The preventing treatment of the breast cancer high risk case( the gene mutation positive case )

Scientific Title:Acronym

The preventing treatment of the breast cancer high risk case

Region

Japan


Condition

Condition

The hereditariness breast cancer high risk group

Classification by specialty

Surgery in general Breast surgery Obstetrics and Gynecology
Adult

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The preventing treatment of the breast cancer high risk case( the gene mutation positive case )

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The preventing treatment of the breast cancer high risk case( the gene mutation positive case )

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

the BRCA gene mutation positive case

Key exclusion criteria

the BRCA gene mutation negative case

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Kitada

Organization

Asahikawa Medical University

Division name

Breast Disease Center

Zip code


Address

Midorigaoka-Higashi 2-1-1-1,Asahikawa, Hokkaido, Japan

TEL

0166-69-3290

Email

k1111@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaori Onishi

Organization

Asahikawa Medical University

Division name

Respiratory Center

Zip code


Address

Midorigaoka-Higashi 2-1-1-1Asahikawa, Hokkaido, Japan

TEL

0166-69-3290

Homepage URL

http://www.asahikawa-med.ac.jp/hospital/respi/

Email

k-onishi@asahikawa-med.ac.jp


Sponsor or person

Institute

Breast Disease Center, Asahikawa Medical University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

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

旭川医科大学病院(北海道)


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 01 Day


Related information

URL releasing protocol

http://www.asahikawa-med.ac.jp/hospital/respi/

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

It does medical examination, an active treatment from the tenderness to the genetic screening positive case.

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

2014 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 01 Day

Last follow-up date

2024 Year 05 Month 01 Day

Date of closure to data entry

2024 Year 05 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2014 Year 04 Month 19 Day

Last modified on

2014 Year 04 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016064


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name