UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057726 |
|---|---|
| Receipt number | R000065962 |
| Scientific Title | Retrospective study on the clinical outcomes of minimally invasive local treatment for early-stage breast cancer |
| Date of disclosure of the study information | 2025/04/26 |
| Last modified on | 2025/04/26 14:41:41 |
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Basic information
Public title
Retrospective study on the clinical outcomes of minimally invasive local treatment for early-stage breast cancer
Acronym
Retrospective study on the clinical outcomes of minimally invasive local treatment for early-stage breast cancer
Scientific Title
Retrospective study on the clinical outcomes of minimally invasive local treatment for early-stage breast cancer
Scientific Title:Acronym
Retrospective study on the clinical outcomes of minimally invasive local treatment for early-stage breast cancer
Region
| Japan |
Condition
Condition
Early breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the clinical significance of the efficacy of less invasive local therapy for early-stage breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy, safety, validation, etc.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients receiving any treatment for breast cancer
Key exclusion criteria
none
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sato |
Organization
Tokyo-West Tokushukai Hospital
Division name
Department of Breast Oncology
Zip code
196-0003
Address
3-1-1 Matsubara, Akishima, Tokyo
TEL
0425004433
kazsato.boc@gmail.com
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sato |
Organization
Tokyo-West Tokushukai Hospital
Division name
Department of Breast Oncology
Zip code
196-0003
Address
3-1-1 Matsubara, Akishima, Tokyo
TEL
09084344853
Homepage URL
kazsato.boc@gmail.com
Sponsor or person
Institute
Clinical research center, Tokyo-West Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mirai Iryo Research Center
Address
1-3-1 KUdan-minami, Chiyoda, Tokyo
Tel
03-3263-4801
https://www.mirai-iryo.com/
Secondary IDs
Secondary IDs
YES
Study ID_1
TGE02745-060
Org. issuing International ID_1
Central IRB in Tokushukai Medical Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.tokyonishi-hp.or.jp/dl/research/mammary-tumor_08.pdf
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
| 2025 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2025 | Year | 04 | Month | 26 | Day |
Last modified on
| 2025 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065962
