Genetic diagnosis of sentinel lymph nodes in malignant melanoma

UMIN ID: UMIN000001097

Registered date:21/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: malignant melanoma
• Date of first enrollment: 2007/12/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: safety of sentinel node biopsy
• Secondary Outcome: efficacy

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Graduate School of Medical Science, Kyushu University
• Secondary Sponsor: Departments of Dermatology, University of Tokyo Hospital, Gunma University Hospital, Okayama University Hospital, University Hospital of Occupational and Environmental Health
• Source(s) of Monetary Support: The health, and labour science research grants from ministry of health, labour and welfare.