Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Assay Metrics
研究概览
简要总结
To study if a targeted gene expression profile of RNA, similar to the NETest, can be isolated from the peripheral blood of patients with melanoma, to identify active disease, provide an assessment of treatment responses, or predict risk of relapse, in conjunction with standard clinical assessment and imaging.
详细描述
- Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage III melanoma at diagnosis (biopsy-proven lymph node positive) and compare this to LDH as a biomarker.
- Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage IV melanoma (including pre-surgery patients as well as those on either targeted or immunotherapy) and compare this to LDH as a biomarker.
- Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.
- Monitor molecular signature levels in blood to assess efficacy of this tool as compared to imaging or other biomarkers to define disease progression or treatment responses in Stage III and IV treated patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Age > 18 years
- •Primary melanoma > 1 mm in Breslow depth
- •Stage III or IV disease as determined either by sentinel node biopsy, biopsy of clinically enlarged lymph nodes, and/or imaging. If stage IV, must have tissue biopsy confirming presence of stage IV melanoma
排除标准
- •Pregnant patients
- •Contraindication to contrasted imaging (due to allergy or renal insufficiency)
- •Serum PCV <30%
结局指标
主要结局
Assay Metrics
时间窗: Up to 24 months
Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.
Efficacy (stage III)
时间窗: Up to 24 months
Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage III melanoma at diagnosis (biopsy-proven lymph node positive) and compare this to LDH as a biomarker.
Molecular signature levels
时间窗: Up to 24 months
Monitor molecular signature levels in blood to assess efficacy of this tool as compared to imaging or other biomarkers to define disease progression or treatment responses in Stage III and IV treated patients.
Efficacy (Stage IV)
时间窗: Up to 24 months
Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage IV melanoma (including pre-surgery patients as well as those on either targeted or immunotherapy) and compare this to LDH as a biomarker
次要结局
未报告次要终点
研究者
Rondi Kauffmann
Principal Investigator
Vanderbilt-Ingram Cancer Center