UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter prospective study of image-guided radiofrequency abltion for small breast carcimonas.
Title of the study (Brief title)	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	Takayuki Kinoshita
Organization	National Cancer Center Hospital
Division name	Division of Breast Surgery
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	takinosh@ncc.go.jp

Public contact
Name of contact person	Takayuki Kinoshita
Organization	National Cancer Center Hospital
Division name	Division of Breast Surgery
Address	5-1-1, Tsukiji, Chuo-ku
TEL	03-3542-2511
Homepage URL
Email	takinsh@ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 12 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010016