Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 27
- 主要终点
- Relapse-free survival
研究概览
简要总结
RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer.
PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage I or stage II melanoma.
详细描述
OBJECTIVES:
- Correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage I or II melanoma.
- Correlate melastatin expression prospectively with event-free survival of these patients.
OUTLINE: This is a multicenter study.
Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.
Patients are followed every 4 months for 3.5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented primary AJCC stage I or II melanoma. Evidence of ulceration, vertical growth phase, regression, lymphocytic infiltration, vascular invasion, microscopic satellitosis, and mitotic rate shall be noted.
- •Patients planning to undergo a sentinel lymph node biopsy, or an elective lymph node dissection of an anatomic draining region from the index primary melanoma.
- •≥18 years of age
- •Patients must be registered prior to planned surgery. The surgery must be performed within 45 days following registration.
- •No concurrent active malignancy other than carcinoma in situ of the cervix and basal cell carcinoma of the skin, or history of any other primary malignancy including previously primary melanoma.
- •Tissue blocks: one of primary tumor tissue taken from region of greatest Breslow thickness. Note: If blocks cannot be sent due to institutional policy, slides may be substituted for the locks per the protocol.
排除标准
- 未提供
研究组 & 干预措施
Group 1
Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.
Patients are followed every 4 months for 3.5 years.
干预措施: comparative genomic hybridization (Genetic)
Group 1
Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.
Patients are followed every 4 months for 3.5 years.
干预措施: cytogenetic analysis (Genetic)
Group 1
Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.
Patients are followed every 4 months for 3.5 years.
干预措施: fluorescence in situ hybridization (Genetic)
Group 1
Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.
Patients are followed every 4 months for 3.5 years.
干预措施: immunohistochemistry staining method (Other)
结局指标
主要结局
Relapse-free survival
时间窗: Up to 3.5 years
次要结局
未报告次要终点