UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on clip custody to axillary lymph node at the time of the breast cancer preoperation chemotherapy enforcement
Title of the study (Brief title)	Study on clip custody to axillary lymph node at the time of the breast cancer preoperation chemotherapy enforcement
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	I examine the validity of the extraction method of the clip custody lymph node using the marking clip custody to axillary lymph node and the pigment as means of the axillary lymph node evaluation precision improvement after the chemotherapy in preoperation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Identification rate of the clip custody lymph node
Key secondary outcomes	False-negative rate when evaluated the clip custody lymph node

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	Maneuver
Interventions/Control_1	Detaining a clip for metastasis to axillary lymph node of the 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Primary breast cancer patient diagnosed cT1-3N1M0 histologically. Patient who plans standard chemotherapy before an operation
Key exclusion criteria	Patient who has more than 3 metastastic axillary lymph node Breast cancer case of the pregnancy period or the period of lactation Bilateral breast cancer patient of synchronism or the heterochrony Patient with a history of other cancer witihn 5 years Patient judged to be inadequate by medical attendant or study person in charge
Target sample size	15

Research contact person
Name of lead principal investigator	Masaru Takemae
Organization	Tochigi Cancer Center
Division name	Department of breast sugery
Address	4-9-13, Yonan, Utsunomiya city, Tochigi, Japan
TEL	028-658-5151
Email	masaruta@tochigi-cc.jp

Public contact
Name of contact person	Masaru Takemae
Organization	Tochigi Cancer Center
Division name	Department of breast sugery
Address	4-9-13, Yonan, Utsunomiya city, Tochigi, Japan
TEL	028-658-5151
Homepage URL
Email	masaruta@tochigi-cc.jp

Sponsor
Institute	Tochigi Cancer Center
Institute
Department

Funding Source
Organization	Tochigi Cancer Center
Organization
Division
Category of Funding Organization	Other
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	2017 Year 11 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 10 Month 18 Day
Anticipated trial start date	2017 Year 10 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 25 Day
Last modified on	2017 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033935