UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038962 |
|---|---|
| Receipt number | 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 | 2026/02/10 17:59:59 |
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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 | Masafumi |
| Middle name | |
| Last name | Shimoda |
Organization
Hyogo Medical University
Division name
Division of Breast and Endocrine Surgery
Zip code
6638501
Address
Mukogawa 1-1, Nishinomiya City, Hyogo 663-8501
TEL
0798456374
shimoda@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Shimoda |
Organization
Hyogo Medical University
Division name
Division of Breast and Endocrine Surgery
Zip code
663-8501
Address
Mukogawa 1-1, Nishinomiya City, Hyogo 663-8501
TEL
0798456374
Homepage URL
shimoda@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical university
Institute
Department
Personal name
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 Medical University
Address
Mukogawa 1-1, Nishinomiya City, Hyogo 663-8501
Tel
+81798456374
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
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044433
