跳至主要内容
临床试验/NCT01492127
NCT01492127Unknown不适用

Evolution of Plasma Proteasome Levels Following Curative Treatment of Hepatocellular Carcinoma in Cirrhotic Patients

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2011年12月最近更新:
适应症
干预措施

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

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

No Intervention

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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