UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020805
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email k-takano@ks.kyorin-u.ac.jp

Sponsor
Institute Department of Breast Surgery, School of Medicine Kyorin University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024018

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.