UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020805 |
|---|---|
| Receipt number | R000024018 |
| Scientific Title | Phase II study on radiofrequency ablation in early breast cancer |
| Date of disclosure of the study information | 2016/01/30 |
| Last modified on | 2016/02/03 16:23:48 |
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Basic information
Public title
Phase II study on radiofrequency ablation in early breast cancer
Acronym
Radiofrequency ablation in early breast cancer
Scientific Title
Phase II study on radiofrequency ablation in early breast cancer
Scientific Title:Acronym
Radiofrequency ablation in early breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate utility of radiofrequency ablation (RFA) in breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Breast deformity after RFA
Key secondary outcomes
adverse events QoL ipsilateral breast tumor recurrence
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
RFA with LeVeen needle electrode and generator
Insertion into the referent tumor under ultrasound guidance
Ablation completed twice until so-called roll off with increase of watts by generator
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
T1 and sentinel node-negative breast cancer (BC) patients were eligible
Key exclusion criteria
BC with diffuse calcification or extensive intraductal component (EIC) was excluded.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Imoto |
Organization
School of Medicine Kyorin University
Division name
Department of Breast Surgery
Zip code
Address
6-20-2 Shinkawa Mmitaka Tokyo 181-8611, JAPAN
TEL
0422-47-5511
imoto@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Takano |
Organization
School of Medicine Kyorin University
Division name
Department of Breast Surgery
Zip code
Address
6-20-2 Shinkawa Mmitaka Tokyo 181-8611, JAPAN
TEL
0422-47-6273
Homepage URL
k-takano@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Breast Surgery, School of Medicine Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Grant for Scientific Research Expenses for Health, Labour and Welfare Programs and the Foundation for the Promotion of Cancer Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
杏林大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2009 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 30 | Day |
Last modified on
| 2016 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024018
