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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023129
Receipt No. 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

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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
Email 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
Email jufoasam@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026148

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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