Study to Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (R0)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection
研究概览
简要总结
Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up
详细描述
The ct DNA R0 study is a prospective, open labelled, monocentric trial. The aim is to evaluate the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up.
The patient will have a blood sample before and after the surgery and during the post-surgery follow-up. The patient will have a maximum of 10 blood samples during the 2 years of his follow-up of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0).
- •No other distant metastasis (CT thoracic -abdomino -pelvic, bone scan).Measurable metastatic disease (echography, CT and/or MRI, FDG-PET, (fluoro- D-glucose integrated with computed tomography)).
- •Patient able to stand a blood collection.
- •Patient explanation given and consent information signed or by legal representative.
排除标准
- •Patient without social protection / insurance..
- •Patient with hepatic metastasis unresectable by surgery
- •Patient with extra-hepatic metastasis.
- •Person deprived of liberty or under guardianship
- •Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.
研究组 & 干预措施
Biological/Vaccine
干预措施: Blood sampling (Biological)
结局指标
主要结局
Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection
时间窗: Up to one month
Comparison the circulating tumor DNA rate before/after surgery and the rate of effective complete resection.
次要结局
- Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis.(Up to one month)
- Study of the correlation between the variation rate of the circulating tumor DNA at different points (T0, T1, T2, T3, T4 and Tn) and the apparition time of metastasis on hepatic MRI during the study follow-up.(two years)
- Detection of GNA11 or GNAQ mutation on one of the hepatic metastasis(Up to one month)
- Histological study of the resected hepatic metastasis (inflammation, Ki 67, necrosis, fibrosis and vascularization, genomic analysis of the metastasis)(Up to one month)
- stability of the circulating tumor DNA on 2 pre-surgery samples(Up to one month)
- Detection of genetic factors for uveal melanoma(Up to one month)
- Study of overall survival after HMUM resection(5 years)