UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013836 |
|---|---|
| Receipt number | R000016147 |
| Scientific Title | Phase II study on radiofrequency ablation in stage 0 and I breast cancer without extensive intraductal components |
| Date of disclosure of the study information | 2014/04/30 |
| Last modified on | 2014/04/28 19:22:22 |
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Basic information
Public title
Phase II study on radiofrequency ablation in stage 0 and I breast cancer without extensive intraductal components
Acronym
Phase II study on radiofrequency ablation in stage 0 and I breast cancer
Scientific Title
Phase II study on radiofrequency ablation in stage 0 and I breast cancer without extensive intraductal components
Scientific Title:Acronym
Phase II study on radiofrequency ablation in stage 0 and I breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We conducted a phase II study on radiofrequency ablation in stage 0-I breast cancer without extensive intraductal components to evaluate an alternative to breast-conserving surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
pathological complete ablation rate
Key secondary outcomes
safety of RFA procedure, cosmetic outcome after RFA, 10-year relapse-free survival, 10-year overall survival
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
thermal ablation of RFA in breast cancer
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
Female
Key inclusion criteria
1. Written informed consent is obtained.
2. Histologically invasive or noninvasive breast cancer.
3. stage 0 (TisN0M0) or I (T1N0M0 or T1N1miM0).
4. pN0(sn) or pN1mi(sn).
5. Image diagnosis of mammogram, ultrasound, and MR mammogram satisfies the following conditions: tumor with 2cm or less in diameter including extensive intraductal components, tumor not near the nipple-areolar complex, no skin retraction above the tumor, no multifocality, and/or limited microcalcification of the tumor.
Key exclusion criteria
male breast cancer.
bilateral breast cancer.
pregnant women or case with lactating breast.
special type of breast cancer, e.g. lobular carcinoma.
Target sample size
32
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 Mitaka 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 | 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
Homepage URL
imoto@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
Department of Breast Surgery, School of Medicine Kyorin University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okinawa Red Cross Hospital
Rinku General Medical Center
National Defense Medical College
Kameda Medical Center
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
| 2014 | Year | 04 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 28 | Day |
Last modified on
| 2014 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016147
