NCT00952939已完成不适用
Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of patients that have Disease Free Survival (DFS) with primary uveal melanoma with and without high-risk genotypes
研究概览
简要总结
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This clinical trial is studying tumor samples in patients undergoing surgery or radiation therapy for primary melanoma of the eye.
详细描述
OBJECTIVES:
Primary
- To establish the feasibility of using fine needle aspiration (FNA) and FISH to determine tumor genotype in patients with primary uveal melanoma.
Secondary
- To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.
- To estimate disease-free survival in patients with and without tumor monosomy 3 and/or 8q amplification.
- To explore the relationship between tumor monosomy 3 and 8q amplification and plasma levels of tumor immune escape and invasion biomarkers (e.g., circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E- cadherin).
- To explore the psychological impact of prognostication in uveal melanoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of patients that have Disease Free Survival (DFS) with primary uveal melanoma with and without high-risk genotypes
时间窗: 2 years
DFS will be measured from the date of initial treatment to the date of documented recurrence or death. It will be summarized using the method of Kaplan and Meier.
次要结局
- distribution of particular markers at specific timepoints(at baseline, multiple time points up to 2 years)
- Number of patients with adverse events to determine ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.(2 years)
- The rate that sufficient tissue can be obtained by FNA.(2 yrs)
研究者
研究点 (1)
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