UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038356 |
|---|---|
| Receipt number | R000043713 |
| Scientific Title | Multicenter observational study for determination of prognostic factors in metastatic breast cancers |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2026/02/10 17:58:34 |
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Basic information
Public title
Multicenter observational study for determination of prognostic factors in metastatic breast cancers
Acronym
Multicenter observational study
Scientific Title
Multicenter observational study for determination of prognostic factors in metastatic breast cancers
Scientific Title:Acronym
Multicenter observational study for determination of prognostic factors in MBC
Region
| Japan |
Condition
Condition
Locally advanced and metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Determination of metastatic breast cancer
Basic objectives2
Others
Basic objectives -Others
Identification of biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PFS, OS
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
Patients treated with drugs for metastatic breast cancer
Key exclusion criteria
None
Target sample size
600
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
663-8501
Address
Mukogawa-cho 1-1
TEL
+81798456374
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
Nishinomiya City, Hyogo 663-8501
TEL
+81798456374
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
Kansai Rosai hospital, Yao Municipal hospital, Hyogo Prefectural Amagasaki General Medical Center, Kobe City Medical Center General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Hyogo Medical University
Address
Mukogawa-chi 1-1, Nishinomiya city
Tel
+81798456374
shimoda@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
| 2019 | Year | 11 | 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
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2019 | Year | 10 | Month | 22 | 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=R000043713
