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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019342
Receipt No. R000022351
Scientific Title Lymphatic flow changes after sentinel lymph node biopsy in primary cutaneous malignant melanoma
Date of disclosure of the study information 2015/10/14
Last modified on 2015/10/15

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Basic information
Public title Lymphatic flow changes after sentinel lymph node biopsy in primary cutaneous malignant melanoma
Acronym Lymphatic flow changes
Scientific Title Lymphatic flow changes after sentinel lymph node biopsy in primary cutaneous malignant melanoma
Scientific Title:Acronym Lymphatic flow changes
Region
Japan

Condition
Condition Malignant melanoma
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study changes of lymphatic flow from sites of primary tumors to regional lymph nodes after sentinel lymph node biopsy in Japanese patients with primary cutaneous malignant melanoma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Lymphatic flow changes after sentinel lymph node biopsy. The times between SLNB and the second NIR imaging were from 22 days to 786 days (average: 101.6 days).
Key secondary outcomes Safety and efficacy of sentinel lymph node biopsy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The agent for the NIR imaging was prepared as follows. Human serum albumin (5 mg), indocyanine green (ICG; Diano-green; Daichi Pharmaceutical, Tokyo, Japan)(0.6 mg) and Patent Blue (Wako Pure Chemical Industries, Ltd.) (6 mg) were dissolved in 1 mL of pure water. The ICG was visualized using a fluorescence imaging system (Photo Dynamic Eye; PDE, Hamamatsu Photonics, Japan) that includes a small charge-coupled-device camera with an integrated near-infrared (NIR) LED light source (energy: 4 mW; wavelength: 760 nm). An 820-nm band-path filter was employed to collect NIR radiation and to reject visible light. The fluorescence signals were sent to a digital video processor for display on a TV monitor. Videos were taken of the dye-injection process, the pulsing of collecting vessels and the overall lymphatic vessels.
Second-time NIR imaging of lymphatic flow after SLNB were also performed.
The times between SLNB and the second NIR imaging were from 22 days to 786 days (average: 101.6 days).
NIR imaging after SLNB was also performed using the same NIR imaging methods as those of the first-time NIR imaging before SLNB, described above.
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 Primary cutaneous malignant melanoma lesions with more than 1mm thickness or lesions estimated to be at Clark level IV, V.
The tumor thickness was estimated by clinical features, dermoscopic findings and images of echogram, CT or MRI.
Key exclusion criteria Patients with PCMM apparently <1.0 mm thick clinically were excluded. Patients with apparent regional lymph node involvement were excluded. Patients in whom apparent metastatic lesions were found by physical and imaging examinations were also excluded.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Akiyama
Organization Nagoya University Graduate School of Medicine
Division name Department of Dermatology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2314
Email makiyama@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Yokota
Organization Nagoya University Graduate School of Medicine
Division name Department of Dermatology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2314
Homepage URL
Email kyokota@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 10 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 13 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
2015 Year 10 Month 14 Day
Last modified on
2015 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022351

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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