UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024452 |
|---|---|
| Receipt number | R000028146 |
| Scientific Title | Sentinel lymph node biopsy for non-melanoma skin cancers |
| Date of disclosure of the study information | 2016/10/18 |
| Last modified on | 2019/04/22 16:09:38 |
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Basic information
Public title
Sentinel lymph node biopsy for non-melanoma skin cancers
Acronym
SLNB for NMSC
Scientific Title
Sentinel lymph node biopsy for non-melanoma skin cancers
Scientific Title:Acronym
SLNB for NMSC
Region
| Japan |
Condition
Condition
non melanoma skin cancers
Classification by specialty
| Dermatology | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and the effectiveness of SLNB for non melanoma skin cancers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
incidence of adverse events, sensitivity, specificity, false positive rate, false negative rate
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
sentinel lymph node biopsy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The diameter of the primary lesion is more the 3 cm.
Key exclusion criteria
The patients who have definite lymph node metastasis or distant metastasis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Ihn |
Organization
Kumamoto university
Division name
Department of Dermatology and Plastic Surgery
Zip code
Address
1-1-1, Honjo, Chuo-ku, kumamoto
TEL
096-373-5233
derma.prs.ku@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Fukushima |
Organization
Kumamoto university
Division name
Department of Dermatology and Plastic Surgery
Zip code
Address
1-1-1, Honjo, Chuo-ku, kumamoto
TEL
096-373-5233
Homepage URL
derma.prs.ku@gmail.com
Sponsor or person
Institute
Kumamoto university
Institute
Department
Personal name
Funding Source
Organization
Kumamoto university
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 10 | Month | 18 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 18 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028146
