Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Measuring the number of circulating melanoma cells/ml in blood
研究概览
简要总结
Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as a prognostic factor and predictor of therapeutic response. The detection of CTC by immunomagnetic method has proved its reliability and its usefulness for monitoring breast cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch, Veridex LLC) was approved by the FDA in these indications. However, to date there is no reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA by reverse specific melanoma is disappointing. Recently, a new detection system of CMC immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the advantage of combining immunomagnetic selection step and a step of identifying by immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown encouraging results. The investigators propose a prospective study of the CellSearch system in patients with melanoma.
Primary objective: To determine the effect of treatment on the number of circulating melanoma cells in patients with metastatic melanoma.
Secondary objectives:
- determine the percentage of patients with metastatic melanoma with melanoma cells circulating
- seek a relationship between the number of circulating melanoma cells and prognosis in patients with metastatic melanoma
- seek a relationship between the change in the number of circulating melanoma cells before / after treatment and tumor response in patients with metastatic melanoma
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
- 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
- •Patients > or = 18 years
- •Patients with advanced melanoma stage IIIC (unresectable) or stage IV
- •Patient not treated or not responding to chemotherapy with chemotherapy session last> 1 month
- •Patients who signed informed consent
- •Patients presenting no socio-economic, psychological, familial or geographical allow proper understanding of the information leaflet of the protocol or the regular monitoring in the department of dermatology
- •Patients with a life expectancy greater than 3 months
- •Patients with melanoma measurable by RECIST version 1.1
- •Patients with venous good for venipuncture
排除标准
- •Patients with contraindication for treatment with chemotherapy or V600E BRAF inhibitor or ipilimumab or have conditions concomitant heavy may interfere with the treatment of metastatic melanoma
- •Pregnant women or nursing
- •People vulnerable detainees, adults under guardianship or curatorship, minors.
结局指标
主要结局
Measuring the number of circulating melanoma cells/ml in blood
时间窗: baseline and 3 months
Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.
次要结局
- Difference in survival(baseline and 6 months)
- number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test(3 months)
- Difference in tumor response(6 months)