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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001162
Receipt No. R000001410
Scientific Title Evaluation of safety and usefulness of sentinel node biopsy in the patients with malignant melanoma
Date of disclosure of the study information 2008/05/20
Last modified on 2010/06/07

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Basic information
Public title Evaluation of safety and usefulness of sentinel node biopsy in the patients with malignant melanoma
Acronym Sentinel node biopsy in melanoma
Scientific Title Evaluation of safety and usefulness of sentinel node biopsy in the patients with malignant melanoma
Scientific Title:Acronym Sentinel node biopsy in melanoma
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safety and usefulness of sentinel lymph node biopsy in the Japanese patients with primary cutaneous melanoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety of sentinel node biopsy
Key secondary outcomes Efficacy

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 Patients undergo cutaneous lymphoscintigraphy with radiopharmaceuticals, either one day before or on the day of the operative procedure. Using the lymphoscintigraphic images, the skin site corresponding to the highest accumulation of radioparticles is identified and marked. At the time of surgery, patent blue violet or diagnogreen is injected intradermally at the primary tumor site. An incision is preformed on the skin site which is most radioactive by gamma-probe. The lymph node(s) stained with the blue dye (patentblue) or fluorescence (diagnogreen) and most radioactive is identified and excised. The excised node(s) is processed for histopathologic examination and the presence of metastases is evaluated using sections stained with hematoxylin and eosin (H&E). If metastases are not detected by H&E staining of the first section, then additional sections are cut from the bivalved lymph nodes and stained with the murine monoclonal antibodies Mart1 (MelanA), HMB-45 and S-100 for immunohistochemical evaluation. If metastases are detected in the sentinel node(s), then curative lymph node dissection is performed.
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 Patients with a primary cutaneous melanoma without any clinical evidence of metastatic disease and with the primary lesion 1mm or more in thickness or with Clark's levels IV and V, or the primary lesion with ulceration irrespective of the thickness.
Key exclusion criteria Patients with distant metastasis.
Patients with severe liver dysfunction.
Pregnant, possible pregnant or feeding women.
Patients without informed consent.
Patients regarded as not adequate for this study by physicians.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Saida
Organization School of Medicine, Shinsu University
Division name Department of Dermatology
Zip code
Address Asahi 3-1-1, Matsumoto 390-8621
TEL 0263-37-2647
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Uhara
Organization School of Medicine, Shinsu University
Division name Department of Dermatology
Zip code
Address Asahi 3-1-1, Matsumoto 390-8621
TEL 0263-37-2647
Homepage URL
Email

Sponsor
Institute School of Medicine, Shinsu University
Institute
Department

Funding Source
Organization The health, and labour science research grants from Ministry of Health, Labour and Welfare.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2008 Year 05 Month 20 Day

Related information
URL releasing protocol
Publication of results 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 Completed
Date of protocol fixation
2008 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 05 Month 20 Day
Last modified on
2010 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001410

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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