UMIN-CTR Clinical Trial

Basic information
Public title	Sentinel lymphnode biopsy treated with local anesthesia - efficacy and safety -
Acronym	Sentinel lymphnode biopsy treated with local anesthesia - efficacy and safety -
Scientific Title	Sentinel lymphnode biopsy treated with local anesthesia - efficacy and safety -
Scientific Title:Acronym	Sentinel lymphnode biopsy treated with local anesthesia - efficacy and safety -
Region	Japan

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

Objectives
Narrative objectives1	efficacy and safety of Sentinel lymphnode biopsy treated with local anesthesia
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	detection rate of sentinel lymphnode
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	pretreat with local anesthesia ahead of RI injection
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	85 years-old >=
Gender	Female
Key inclusion criteria	application of sentinel lymph node biosy no allergy against local anesthesia informed consent
Key exclusion criteria	allergy against local anesthesia
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Shinichiro Middle name Last name Kubo
Organization	Fukuyama City Hospital
Division name	Breast and Thyroid Surgery
Zip code	721-8511
Address	Zao-cho 5-23-1, Fukuyama, Hiroshima, Japan
TEL	084-941-5151
Email	Shimin-byouin@city.fukuyama.hiroshima.jp

Public contact
1st name of contact person	1st name Shinichiro Middle name Last name Kubo
Organization	Fukuyama City Hospital
Division name	Breast and Thyroid Surgery
Zip code	721-8511
Address	Zao-cho 5-23-1, Fukuyama, Hiroshima, Japan
TEL	084-941-5151
Homepage URL
Email	Shimin-byouin@city.fukuyama.hiroshima.jp

Sponsor
Institute	Fukuyama City Hospital
Institute
Department

Funding Source
Organization	Fukuyama City Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB(Fukuyama City Hospital)
Address	Zao-cho 5-23-1, Fukuyama, Hiroshima, Japan
Tel	084-941-5151
Email	Shimin-byouin@city.fukuyama.hiroshima.jp

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	2019 Year 03 Month 31 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	2019 Year 02 Month 04 Day
Date of IRB	2019 Year 02 Month 04 Day
Anticipated trial start date	2019 Year 02 Month 04 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 31 Day
Last modified on	2019 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040185