Sensitive RT-PCR Analysis for Melanoma Markers From Lymph Nodes and Peripheral Blood in Patients With Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease
研究概览
简要总结
RATIONALE: Diagnostic procedures may improve the ability to detect the presence or recurrence of disease.
PURPOSE: Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood of patients who have melanoma.
详细描述
OBJECTIVES:
- Determine the feasibility of performing reverse transcriptase-polymerase chain reaction (RT-PCR) for five different tumor antigen genes using lymph node samples or peripheral blood from patients with melanoma.
- Determine the ability of PCR-positive lymph nodes or peripheral blood to predict relapse of disease in these patients.
- Determine the correlation of positive PCR results from peripheral blood with disease stage.
OUTLINE: Lymph node biopsies or peripheral blood are obtained from patients. These specimens are examined by nested reverse transcriptase-polymerase chain reaction (RT-PCR) and analyzed for various tumor antigens.
Patients may choose to be told the results of this testing, but the results do not influence or change the planned therapy. Brief counseling is required to discuss the results and their potential implications.
Patients are followed for at least 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease
时间窗: 3 years
次要结局
未报告次要终点