Evolution of Plasma Proteasome Levels Following Curative Treatment of Hepatocellular Carcinoma in Cirrhotic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Variation of plasma proteasome
研究概览
简要总结
This study will evaluate the usefulness of plasma proteasome levels as a tumor marker of hepatocellular carcinoma (HCC) by studying their variation following curative treatment of HCC. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence.
详细描述
HCC occurs in the vast majority of cases in the context of cirrhosis. Cirrhosis is considered a pre-cancerous state, which justifies systematic screening for HCC. Screening currently relies on measurement of alpha-foetoprotein (AFP) levels and ultrasound scans every 4 to 6 months. However, AFP has poor sensitivity as a marker for HCC. We have recently shown that plasma proteasome levels have a higher sensitivity than HCC for detecting HCC in cirrhotic patients, particularly when the tumors are small and can still benefit from curative treatment. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence. The goal of this study is to determine whether plasma proteasome levels in cirrhotic patients with HCC decrease following curative treatment (radiofrequency, surgical resection, liver transplantation). Plasma proteasome levels will be measured before treatment and 3 months after treatment, then subsequently at 3 month intervals over one year following treatment. The variation of proteasome levels will be compared to AFP levels. The sensitivity of proteasome as a marker to detect tumor recurrence will be evaluated, and compared to AFP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Cirrhotic patients with hepatocellular carcinoma proven by histological examination of a biopsy specimen, eligible for curative treatment (radiofrequency, surgical resection, liver transplantation)
- •Patient able to give informed consent
- •Patient with Social Security coverage
排除标准
- •Secondary liver tumors
- •Non hepatocellular carcinoma primary liver tumor
- •Hepatocellular carcinoma without cirrhosis
- •Patients with hepatocellular carcinoma and cirrhosis not eligible for curative treatment
- •Prisoners
- •Adults under guardianship or curatorship
- •Pregnancy
研究组 & 干预措施
Blood test
Blood test :carcinoma in cirrhotic patients
干预措施: Blood test (Biological)
结局指标
主要结局
Variation of plasma proteasome
时间窗: 3 months afterwards
Variation of plasma proteasome levels before curative treatment of HCC and 3 months afterwards
次要结局
- Variation of plasma proteasome(6, 9 and 12 months)
