UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036358 |
|---|---|
| Receipt number | 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 13:22:22 |
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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
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
Shimin-byouin@city.fukuyama.hiroshima.jp
Sponsor or person
Institute
Fukuyama City Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040185
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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