he Application of DNA Methylation for Patients Who Had Hepatocellular Carcinoma With Normal Serum Alpha-fetoprotein
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The correlation between serum DNA methylation and HCC recurrence or treatment response
研究概览
简要总结
The goal of this single-arm prospective study is to evaluate the application of serum DNA methylation for HCC patients with normal alpha-fetoprotein. The main question it aims to answer is
. Is the dynamic change of serum DNA methylation correlated to recurrence or treatment response of HCC
详细描述
The enrolled individuals with HCC and normal serum alpha-fetoprotein level would receive serum DNA methylation test before their treatment (including all kinds of recommened HCC treatment). Then regularly serum DNA methylation test would be done at 4th~8th weeks, 16th week, 32th week and 48th week. If the enrolled patients did not have HCC recurrence during at 48th week. The regular check of serum DNA methylation would be canceled. The enrolled patients would be observed till 96th week. If there is any recurrence during 48~96th week, one time of serum DNA methylation would be checked at the time of recurrence. The observation and intervention would be completed at 96th week.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years old
- •The diagnosis of hepatocellular carcinoma (HCC) according to AASLD 2018 clinical guidelines or histology report
- •Individuals with HCC and normal serum alpha-fetorpotein level (<20 ng/ml)
- •Individuals who could sign informed consent
排除标准
- •The histology report revealed non-HCC, HCC mixed with cholangiocarcinoma or sarcomatoid HCC
- •Individuals with HCC and other concurrent malignancies
- •Individuals with chronic kidney disease who could not tolerate contrast-enhanced dynamic images
- •Individuals ever receiving any organ transplantation
- •Individuals with HIV infection
- •Individuals who could not able to understand and sign informed consent
结局指标
主要结局
The correlation between serum DNA methylation and HCC recurrence or treatment response
时间窗: 96 weeks
The correlation between serum DNA methylation and HCC recurrence or treatment response
次要结局
未报告次要终点