Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in tcNA dosage between baseline and 6 Months
研究概览
简要总结
The goal of the REMNANT study is to confirm the clinical value of detecting a new biomarker, ctDNA (circulating tumor DNA), in the follow-up of patients with operated liver cancer. In order to meet this objective, this biomarker will be measured in your blood before and after surgery, at three and six months.
详细描述
Hepatocellular carcinoma (HCC) is the most common primary liver cancer and develops in 80% of cases in the context of underlying cirrhosis1. Surgical resection, percutaneous destruction and liver transplantation are the three treatments considered curative with a non-negligible risk of recurrence of 35-50% at 2 years2.
Several data in the literature suggest that small subclinical tumors can be detected by circulating tumor DNA (ctDNA), and that the amount of tcDNA detected seems to correlate with risk factors for recurrence such as tumor size or microvascular invasion3, 4.
The objective of this pilot study is to evaluate the detection of ctDNA following tumor ablation and its impact on early recurrence.
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
- •Age ≥ 18 years
- •HCC diagnosed on consensus radiological criteria in cirrhotic patients (EASL-EORTC 2012): helical CT or MRI with triple arterial, portal and late acquisition. The diagnosis is based on the presence of hypervascularization at the early arterial time (wash-in) with wash-out (hypodensity or hypointensity compared to non-tumor liver parenchyma) at the portal phase or late phase compared to non-tumor parenchyma.
- •HCC diagnosed histologically in the absence of a diagnosis on imaging (see IC n°2 above)
- •Patient operated on for liver resection or radiofrequency destruction
- •Treatment decision validated by the digestive oncology PCR
- •Patient having read and understood the information letter and signed the non-opposition form
- •Patient follow-up at the Charles Nicolle University Hospital in Rouen
排除标准
- •Other active cancer or hematological malignancy
- •Contra-indication to surgery
- •Patient not affiliated to the social security system
- •Pregnant woman or parturient or breastfeeding
- •Person under court protection, sub guardianship or curatorship
研究组 & 干预措施
Patient with hepatocellular carcinoma
Circulating tumor DNA dosage will be done to patients with hepatocellular carcinoma
干预措施: circulating tumor DNA dosage (Other)
结局指标
主要结局
Change in tcNA dosage between baseline and 6 Months
时间窗: 6 months
evolution of tcDNA percentage between Baseline and at 6 months after surgery
Change in tcDNA dosage between baseline and 3 Months
时间窗: 3 months
evolution of tcDNA percentage between Baseline and at 3 months after surgery
次要结局
- Survival at 2 years(2 years)