Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Incidence of hepatocellular carcinoma diagnosis
研究概览
简要总结
Patients with liver cirrhosis are at high risk of developing hepatocellular carcinoma (HCC) which implies significant mortality. At present current surveillance methods detect hepatocellular carcinomas at a late stage resulting in few treatment options for patients and, in the majority of cases, premature death.
The goal of this study is to implement Elecsys® GAAD in real-world hepatocellular carcinoma surveillance for those with liver cirrhosis.
The main questions it aims to answer are:
- Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway increase early detection of HCC?
- Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway reduce false positive tests and unnecessary confirmatory investigations?
- Does the new surveillance pathway improve adherence?
Researchers will compare Elecsys® GAAD with standard of care tests to see if it results in earlier detection of hepatocellular carcinoma and will explore potential improvements to the surveillance pathway.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance
排除标准
- •Pregnancy/breast-feeding.
- •Patients who do not have liver cirrhosis
- •Patients who already have hepatocellular carcinoma
- •Any patient who is unable to understand, retain and weigh information to make an informed decision, will be excluded from the study. The investigators will use every opportunity, including tele-interpretation services to minimise this from happening.
结局指标
主要结局
Incidence of hepatocellular carcinoma diagnosis
时间窗: 2 years
Incidence recorded as number of cases per study cohort
Stage of hepatocellular carcinoma at diagnosis
时间窗: 2 years
Barcelona Clinic Liver Cancer (BCLC) stage 0-D
次要结局
- Rates of discontinuation(2 years)
- Rates of curative treatment(2 years)
- Rates of adherence(2 years)
- Survival rates(7 years)
- Rates of false positives for each combination of diagnostic tests(2 years)