UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035972 |
|---|---|
| Receipt number | R000037409 |
| Scientific Title | Subtotal integumentectomy for treatment of malignant melanoma with indocyanine green(ICG) |
| Date of disclosure of the study information | 2019/02/22 |
| Last modified on | 2019/02/21 18:27:51 |
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Basic information
Public title
Subtotal integumentectomy for treatment of malignant melanoma with indocyanine green(ICG)
Acronym
Subtotal integumentectomy for treatment of malignant melanoma
Scientific Title
Subtotal integumentectomy for treatment of malignant melanoma with indocyanine green(ICG)
Scientific Title:Acronym
Subtotal integumentectomy for treatment of malignant melanoma
Region
| Japan |
Condition
Condition
malignant melanoma
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In malignant melanoma, in-transit metastasis occur at a frequency of 5 to 10% after the excision of the primary tumor and the regional lymph node dissection. In-transit metastasis is thought to be the cause of proliferation of tumor cells remaining in lymphatic vessels between the primary tumor and the regional lymph nodes. Previously, to prevent in-transit metastasis, subtotal integumentectomy has been performed. Conventionally, it was difficult to noninvasively identify lymphatic vessels, but indocyanine green (ICG) lymphangiography, which was recently developed, visualizes the lymphatic vessels in real time. The purpose of this study is to indicate the effectiveness and safety of subtotal integumentectomy with indocyanine green (ICG) lymphangiography for the treatment of malignant melanoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Relapse-free survival
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
| Maneuver |
Interventions/Control_1
We will perform surgery under general anesthesia. We inject Indocyanine Green (ICG) into the primary tumor of the limbs. We use lymphography to confirm sentinel lymph nodes and lymph flow. We conduct sentinel lymph node biopsy. When we confirmed sentinel lymph node metastasis by intraoperative rapid pathologic diagnosis, we perform regional lymph node dissection, excision of lymphatic duct, and resection of primary tumor. All wounds should be wrapped as appropriate so as not to be impossible.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subject has malignant melanoma of the thigh or brachial primary, and has regional lymph node metastasis.
The subject must be over 20 years old at the acquisition date.
The subject can be determined to participate in the study at their own will.
Key exclusion criteria
Subjects have a history of severe hypersensitivity and side effects in Indocyanine green (ICG).
Subjects suffer from malignant tumors within 5 years.
Subjects suffer from acute myocardial infarction, unstable angina, myocarditis, cerebral infarction within 3 months.
Subjects have remarkably unstable circulation dynamics due to severe heart failure, arrhythmia, etc.
Subject has active infection.
Subjects may be pregnant or pregnant
Subject's serum albumin is less than 2g/dl.
We can not identify lymph flow with ICG during surgery.
In addition, when the doctor in charge judges the subject as inappropriate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Ihn |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Dermatology and Plastic Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto 860-8556, Japan
TEL
0963735233
ihn-der@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Aoi |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Dermatology and Plastic Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto 860-8556, Japan
TEL
0963735233
Homepage URL
junjunaoi@gmail.com
Sponsor or person
Institute
Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University 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
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
| 2019 | Year | 02 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 21 | Day |
Last modified on
| 2019 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037409
