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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001097
Receipt No. R000001243
Scientific Title Genetic diagnosis of sentinel lymph nodes in malignant melanoma
Date of disclosure of the study information 2008/04/21
Last modified on 2011/03/29

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Basic information
Public title Genetic diagnosis of sentinel lymph nodes in malignant melanoma
Acronym Sentinel node biopsy in malignant melanoma
Scientific Title Genetic diagnosis of sentinel lymph nodes in malignant melanoma
Scientific Title:Acronym Sentinel node biopsy in malignant melanoma
Region
Japan

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

Objectives
Narrative objectives1 The detection of micro metastases in sentinel lymph node (SLN) in malignant melanoma patients let us perform lymph disection, to improve the prognosis of this desease. To increase the sentsitivity of the detection of metastases in SLN, SLN is analysed histologically and by immunohistochemistry and RT-PCR method. We assess the safty and efficacy of sentinel node biopsy and its diagnosis in early stage malignant 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 Biopsy of sentinel lymph node in maelanoma patients .
A day before surgery, 0.4 ml of 99m-Tc labeled phytate is injected intradermally around primary tumor. The sentinel node(s) is located by scintilation camera. Just befor surgery, 0.5-1 ml of 1% patent blue is injected intradermally around primary tumor. The blue and radioactive node(s) is detected using a gamma counter, and is dissected. The obtained node(s) is analysed histologically and by immunohistochemistry and RT-PCR method. The patient with positive (metastatic) sentinel node is underwent lymph dissection.
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 The malignant melanoma patient without distant metastases have following characteristics.
1.The thickness of primary tumor is assecced more than 1mm.
2. The primary lesion shows ulceration.
Key exclusion criteria Patient with distant metastasis.
Patient with severe liver dysfunction.
Pregnat, possible pregrnat or feeding women.
Patient without informed concent.
Patient is considered who is not adequate.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Moroi
Organization Graduate School of Medical Science, Kyushu University
Division name Department of Dermatology
Zip code
Address 3-1-1 Maidashi, Higashiku, Fukuoka 812-8582
TEL 092-642-5585
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Moroi
Organization Graduate School of Medical Science, Kyushu University
Division name Department of Dermatology
Zip code
Address 3-1-1 Maidashi, Higashiku, Fukuoka 812-8582
TEL 092-642-5585
Homepage URL
Email

Sponsor
Institute Graduate School of Medical Science, Kyushu 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 Departments of Dermatology, University of Tokyo Hospital, Gunma University Hospital, Okayama University Hospital, University Hospital of Occupational and Environmental Health
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 九州大学病院皮膚科(福岡県)、東京大学病院皮膚科(東京都)、群馬大学病院皮膚科(群馬県)、岡山大学病院皮膚科(岡山県)、産業医科大学病院皮膚科(福岡県)

Other administrative information
Date of disclosure of the study information
2008 Year 04 Month 21 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
Total 99 cases with early stage melanoma have been enrolled at the end of March 2010. No patients have been suffered from adverse event, except for one patient suffered from pulmonary embolization after operation, which was recovered later. 
Only one patient have revealed the lesional node recurrence which was considered as a case with false negative. 
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
2007 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information Because this clinical trial have indicated the safety and efficacy of sentinel lymph node biopsy in melanoma, this examination was covered by the health insurance from April 2010.

Management information
Registered date
2008 Year 03 Month 25 Day
Last modified on
2011 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001243

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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