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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038962
Receipt No. R000044433
Scientific Title Development of diagnosis and treatment strategy for breast cancer based on molecular classification
Date of disclosure of the study information 2020/01/01
Last modified on 2019/12/23

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Basic information
Public title Development of diagnosis and treatment strategy for breast cancer based on molecular classification
Acronym Development of diagnosis and treatment strategy for breast cancer
Scientific Title Development of diagnosis and treatment strategy for breast cancer based on molecular classification
Scientific Title:Acronym Development of diagnosis and treatment strategy for breast cancer
Region
Japan

Condition
Condition Breast Cancer and benign breast disease
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Development of diagnosis and treatment strategy for breast cancer based on molecular classification
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification of factors which predict prognosis and treatment efficacy.
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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Breast cancer patients treated with operation and obtained written informed consent. Patients with metastatic breast cancer and benign breast disease are also incorporated.
Key exclusion criteria Patients who do not received any treatment and patients without written informed consent.
Target sample size 2100

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Miyoshi
Organization Hyogo Collge of Medicine
Division name Division of Breast and Endocrine
Zip code 6638501
Address Nishinomiya City, Hyogo 663-8501
TEL 0798456374
Email ymiyoshi@hyo-med.ac.jp

Public contact
Name of contact person
1st name Yasuo
Middle name
Last name Miyoshi
Organization Hyogo College of Medicine
Division name Division of Breast and Endocrine
Zip code 663-8501
Address Nishinomiya City, Hyogo 663-8501
TEL 0798456374
Homepage URL
Email ymiyoshi@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hyogo College of Medicine
Address Nishinomiya City, Hyogo 663-8501
Tel +81798456374
Email rinri@hyo-med.ac.jp

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
2020 Year 01 Month 01 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 Open public recruiting
Date of protocol fixation
2013 Year 07 Month 22 Day
Date of IRB
2013 Year 08 Month 01 Day
Anticipated trial start date
2013 Year 08 Month 02 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study will be started after obtained written informed consent. Clinical data are obtained will be obtained at the time they are needed.

Management information
Registered date
2019 Year 12 Month 23 Day
Last modified on
2019 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044433

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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