Addition of GAAD Score to Imaging Surveillance for Early Identification of Liver Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The diagnostic value of the GAAD score for HCC
研究概览
简要总结
The goal of this prospective observational study is to test the impact of addition of the GAAD score to imaging in patients with chronic liver disease eligible for HCC surveillance. The main questions it aims to answer are:
- Diagnostic accuracy of the GAAD score (cut-off 2.57 (3)) for detection of HCC (overall and by BCLC stage), expressed using sensitivity, specificity, negative predictive value and positive predictive value.
- Change in GAAD score over time, and proportion of patients with a GAAD score above the cut-off over time in relation to potential confounding factors (e.g. age, bilirubin levels, presence of HCC).
1000 participants with chronic liver disease eligible for HCC surveillance will be enrolled. Data will be collected for 3 consecutive years after enrollment. As per clinical practice, patients will undergo standard bi-annual HCC surveillance comprising liver imaging with ultrasound (or CT or MRI based on previous investigations) and GAAD score assessment based on blood samples.
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
- •All patients with cirrhosis
- •Non-cirrhotic chronic hepatitis B patients meeting any of the following criteria: positive family history for HCC, intermediate-high aMAP and/or (m)PAGE-B score (if non-Caucasian)
- •Non-cirrhotic chronic hepatitis C patients (with or without SVR) with a history of F3 fibrosis (based on histology or liver stiffness assessment)
- •Non-cirrhotic NASH patients with a history of F3 fibrosis (based on histology or liver stiffness assessment)
排除标准
- •Diagnosis with any other cancer other than non-melanoma skin cancer
- •History of HCC
- •Women who are pregnant or lactating
- •Patient with glomerular filtration rate <45 ml /min/1.73 m2
- •Unwillingness or inability to undergo both CT and MRI imaging
- •Life expectancy <2 years
- •Use of vitamin K antagonists
结局指标
主要结局
The diagnostic value of the GAAD score for HCC
时间窗: 6 months
The diagnostic value of the GAAD score for HCC will be expressed using sensitivity, specificity, positive and negative predictive values, both overall and for the subgroup of early stage (BCLC 0-A) HCC. The GAAD scores will be measured and documented separately for each visit. The diagnostic value of the GAAD score will be assessed for HCC diagnosed at the index visit (ie the visit at which the GAAD score was determined) and for HCC diagnosed on imaging performed at 6 months after the index visit.
次要结局
- Change in GAAD score over time in relation to confounding factors(3 years)
研究者
Milan Sonneveld
Associate Professor
Erasmus Medical Center