NCT02875652已完成不适用
Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Assesment of the change of the circulating tumor DNA from baseline at 3 years
研究概览
简要总结
Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma
详细描述
This study is a prospective, open-labelled, monocentric trial. The aim is to observe, in patient with choroidal melanoma (any stage of the disease), the prevalence of the circulating tumor DNA at the diagnostic and its evolution during 3 years.
The patient will have a blood sample at the following times :
- T0: before treatment of the primary tumor.
- T1: 1 months after the end of the local treatment.
- T2: at 7 months.
- Tn: every 6 months up to 3 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
- 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
- •Aged 18 years old or more.
- •Patient with a recent choroidal melanoma before the start of the specific treatment.
- •Patient able to stand a blood collection.
- •Work-up for extension (CT).
- •Patient explanation given and consent information signed or by legal representative
排除标准
- •Patient without social protection / insurance.
- •Person deprived of liberty or under guardianship.
- •Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological
结局指标
主要结局
Assesment of the change of the circulating tumor DNA from baseline at 3 years
时间窗: T0: before treatment; T1: 1 month after local treatment; T2: at 7 months; Tn : every 6 months up to 3 years.
次要结局
- Comparison of the circulating tumor DNA rate to hepatic imaging if available.(3 years)
- Compare the treatment effects of the primary tumor (protontherapy, iodine plaque, enucleation) on the rate of circulating tumoral DNA.(3 years)
研究者
研究点 (2)
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