Unique ID issued by UMIN | UMIN000001162 |
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Receipt number | 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 18:44:08 |
Evaluation of safety and usefulness of sentinel node biopsy in the patients with malignant melanoma
Sentinel node biopsy in melanoma
Evaluation of safety and usefulness of sentinel node biopsy in the patients with malignant melanoma
Sentinel node biopsy in melanoma
Japan |
Malignant melanoma
Dermatology |
Malignancy
NO
To evaluate safety and usefulness of sentinel lymph node biopsy in the Japanese patients with primary cutaneous melanoma
Safety,Efficacy
Confirmatory
Pragmatic
Phase I,II
Safety of sentinel node biopsy
Efficacy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
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.
Not applicable |
Not applicable |
Male and Female
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.
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.
200
1st name | |
Middle name | |
Last name | Toshiaki Saida |
School of Medicine, Shinsu University
Department of Dermatology
Asahi 3-1-1, Matsumoto 390-8621
0263-37-2647
1st name | |
Middle name | |
Last name | Hisashi Uhara |
School of Medicine, Shinsu University
Department of Dermatology
Asahi 3-1-1, Matsumoto 390-8621
0263-37-2647
School of Medicine, Shinsu University
The health, and labour science research grants from Ministry of Health, Labour and Welfare.
Japan
NO
2008 | Year | 05 | Month | 20 | Day |
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Completed
2008 | Year | 03 | Month | 08 | Day |
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2010 | Year | 03 | Month | 01 | Day |
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2010 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001410
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