Study for Clinical Significance of Use of Alphafetoprotein (AFP), AFP-L3 and Des-gamma-carboxy Prothrombin (DCP) Versus US Alone in Surveillance for HCC
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Hepatocellular carcinoma
研究概览
简要总结
This study is intended to be a prospective observational study at multiple sites, not a randomized controlled trial (RCT). The uses of the biomarkers has been approved by government regulations and adopted for surveillance programs in some countries, thus an RCT which compares patients followed by US alone with patients followed by both US and the biomarkers would raise an ethical conflict, especially in countries where the biomarkers have been routinely used.
For this study, enrolled patients will be followed by US and the biomarkers at regular intervals and classified after completing the study to evaluate the clinical effectiveness of the biomarkers. The comparisons of sensitivity, specificity, and other parameters with respect to tumor characteristics will be made among US alone, the biomarkers, and combined use of US and the biomarkers. Also economical effectiveness of using the biomarkers will be investigated in this study.
Requirement status is monitored every month.
详细描述
Data are being stored in the electric data capture (EDC) server.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with compensated cirrhosis. No discrimination by underlying causes will done.
- •Patients aged 18 years and older
- •Patients agree to the informed consent
排除标准
- •Patients with liver cancer at the time of enrollment
- •Patients who have experienced HCC or other malignant tumor with in five (5) years
- •Women with pregnancies
- •Patients who are likely to be transplanted within one (1) year
- •Patients with ≥ 3 mg/dL of total bilirubin
- •Patients with uncontrollable ascites
- •Patients with ≥ Grade II of hepatic encephalopathy
结局指标
主要结局
Hepatocellular carcinoma
时间窗: Expected time frame; 2.5 years
Tumor marker measurement and ultrasonography are conducted at an interval of 13 weeks, until total events (HCC occurrence) reach to 120 cases.
次要结局
- Survival(2 and 5 year after patient enrollment)