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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035972
Receipt No. 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

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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
Email 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
Email junjunaoi@gmail.com

Sponsor
Institute Faculty of Life Sciences, Kumamoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037409

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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