UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023129 |
|---|---|
| Receipt number | R000026148 |
| Scientific Title | Sentinel lymph node detection using radioisotopes in skin cancer |
| Date of disclosure of the study information | 2016/07/12 |
| Last modified on | 2019/07/15 12:47:59 |
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Basic information
Public title
Sentinel lymph node detection using radioisotopes in skin cancer
Acronym
Sentinel lymph node detection in skin cancer
Scientific Title
Sentinel lymph node detection using radioisotopes in skin cancer
Scientific Title:Acronym
Sentinel lymph node detection in skin cancer
Region
| Japan |
Condition
Condition
metastatic skin cancer
Classification by specialty
| Dermatology | Radiology | Plastic surgery |
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study of the significance of sentinel lymph node search inmetastatic skin cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification and localization of sentinel lymph nodes
Key secondary outcomes
Decision of the cut-off value of lymphatic transit rate
indicating negative nodal metastasis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Intracutaneous injections of Technetium-99m-phytate
(6x18.5MBq) around the tumor at lymphoscintigraphy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who were diagnosed with metastatic skin cancer based on histopathological examination.
2. From the results of medical history, physical findings, blood, examination, and urine test, the patients who had no serious complications that could not put them under general anesthesia or lumbar anesthesia.
3. Patients who gave written informed consent.
Key exclusion criteria
1. Patients who are pregnant. Patients who are breast-feeding. Patients with drug allergy to Technetium-99m
-phytate.
2. Patients who did not give written informed consent.
3. Attending physician judged that the patients were inappropriate to participate in the study.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Fujiwara |
Organization
Hamamatsu University School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
431-3192
Address
1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192
TEL
053-435-2798
jufoasam@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Fujiwara |
Organization
Hamamatsu University School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
431-3192
Address
1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192
TEL
053-435-2798
Homepage URL
jufoasam@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan
Tel
053-435-2680, 2972
rinri@hama-med.ac.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
浜松医科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 12 | 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
| 2016 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 12 | Day |
Last modified on
| 2019 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026148
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
