UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008608 |
|---|---|
| Receipt number | R000010016 |
| Scientific Title | A multicenter prospective study of image-guided radiofrequency abltion for small breast carcimonas. |
| Date of disclosure of the study information | 2012/08/08 |
| Last modified on | 2016/08/06 13:57:01 |
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Basic information
Public title
A multicenter prospective study of image-guided radiofrequency abltion for small breast carcimonas.
Acronym
RFA for EBC
Scientific Title
A multicenter prospective study of image-guided radiofrequency abltion for small breast carcimonas.
Scientific Title:Acronym
RFA for EBC
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Surgery in general | Breast surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of RFA for early breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of adeverse event of RFA for breast cancer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
radiofrequency ablation
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
Female
Key inclusion criteria
Early breast cancer
T<= 1cm
Key exclusion criteria
Tumor with unclear margin on US
multiple lesion
ILC
Tumor with wide EIC
micrcalcifications on MMG outside the target lesion
receiving PST
M(+)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Kinoshita |
Organization
National Cancer Center Hospital
Division name
Division of Breast Surgery
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
takinosh@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Kinoshita |
Organization
National Cancer Center Hospital
Division name
Division of Breast Surgery
Zip code
Address
5-1-1, Tsukiji, Chuo-ku
TEL
03-3542-2511
Homepage URL
takinsh@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Research grant from MHLW, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 08 | Month | 08 | 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
Completed
Date of protocol fixation
| 2008 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 03 | Day |
Last modified on
| 2016 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010016
