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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013763
Receipt No. R000016063
Scientific Title The genetic screening to the hereditariness breast cancer high risk group
Date of disclosure of the study information 2014/05/01
Last modified on 2014/04/19

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Basic information
Public title The genetic screening to the hereditariness breast cancer high risk group
Acronym The genetic screening to the hereditariness breast cancer high risk group
Scientific Title The genetic screening to the hereditariness breast cancer high risk group
Scientific Title:Acronym The genetic screening to the hereditariness breast cancer high risk group
Region
Japan

Condition
Condition The hereditariness breast cancer high risk group
Classification by specialty
Surgery in general Breast surgery Obsterics and gynecology
Adult
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The genetic screening to the hereditariness breast cancer high risk group
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes The diagnosis of the BRCA gene 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 hereditariness breast cancer high risk group
Key exclusion criteria The hereditariness breast cancer low risk group
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
Institute Department of Breast Disease Center, Asahikawa Medical University
Institute
Department

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 a genetic screening to the gene breast cancer high risk case.
It does the positive case an active treatment or a thorough follow-up.
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016063

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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