Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood
研究概览
简要总结
Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies.
In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.
详细描述
The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood.
The secondary objectives of this study will be:
- Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma.
- Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •patient with melanoma confirmed histologically
- •patient with metastatic melanoma (stage III unresectable or stage IV)
- •patient consenting to participate to the study
- •patient enrolled in the national healthcare insurance program
- •patient older than 18 years
排除标准
- •- Metastatic tumor whose origin is doubtful (uncertain melanoma)
结局指标
主要结局
Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood
时间窗: Day 0
Number of patients for which a circulating tumor DNA is detected (positivity of at least one marker of the panel)
次要结局
未报告次要终点