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临床试验/NCT03493763
NCT03493763Unknown不适用

Study on Recurrence Monitoring of Hepatocellular Carcinoma With 5-Hydroxymethylcytosine Based on hmC-Seal Technology

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Time of hepatocellular carcinoma recurrence

研究概览

简要总结

In this study, investigators aim to find out how plasma 5hmC level changes in hepatocellular carcinoma patients after liver resection, and determine whether 5hmC can be used as a biomarker for HCC recurrence monitoring.

详细描述

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the third leading cause of cancer-related death worldwide. Liver resection is a common treatment for HCC. However, even after successful surgical resection, most patients suffered from recurrence or progression of the tumor. Because clinical staging systems cannot precisely predict the outcome of patients with HCC, it's of great interest to search biomarkers for HCC. Among them, alpha-fetoprotein (AFP) is the most well-studied. However, the applicability of AFP for HCC after surgical resection of tumor is still uncertain.

The discovery of cell-free DNA (cfDNA) originating from different tissues in the circulating blood has revolutionary potential for the clinic. Liquid biopsy-based biomarkers and detection tools offer substantial advantages over existing diagnostic and prognostic methods, including being minimally invasive. They thus have a cost-efficient potential to promote higher patient compliance and clinical convenience to enable dynamic monitoring.

5-hydroxymethylcytosine (5hmC) is the intermediate of active demethylation from 5-methylcytosine. 5hmC not only marks active demethylation but also serves as a relatively stable DNA mark that plays distinct epigenetic roles. Recent genome-wide sequencing maps of 5hmC in various mammalian cells and tissues support its role as a marker for gene expression. Previous studies have established 5hmC-Seal technology for 5hmC profiling in cfDNA and showed that the differentially enriched 5hmC regions in cfDNA are excellent markers for solid tumors.

In this study, investigators aim to find out how plasma 5hmC profile changes in hepatocellular carcinoma patients after liver resection, and determine whether 5hmC can be used as a biomarker for HCC recurrence monitoring.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who received liver resection within 3 months;
  • Hepatocellular carcinoma confirmed pathologically;
  • Serum alpha-fetoprotein level lower than 20ng/ml before hepatectomy.

排除标准

  • Patients with macroscopic tumor remnants;
  • Patients with other diseases which may affect the observation mentioned here;
  • Patients with medical history of other malignant tumors;
  • Pregnant or nursing women.

结局指标

主要结局

Time of hepatocellular carcinoma recurrence

时间窗: 2 years

Time from the day of liver resection to the day of clinical diagnosis of recurrence

次要结局

  • Serum alpha-fetoprotein level after liver resection(2 years or until tumor recurrence)
  • Adverse effect of 5hmC blood test(2 years)
  • 5hmC level in recurrence-related cfDNA after liver resection(2 years or until tumor recurrence)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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