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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036358
Receipt No. R000040185
Scientific Title Sentinel lymphnode biopsy treated with local anesthesia - efficacy and safety -
Date of disclosure of the study information 2019/03/31
Last modified on 2019/03/31

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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