Use of Blood Biomarkers for the Early Diagnosis of Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Biomarker dosage
研究概览
简要总结
The objective of this observational study is to evaluate the clinical utility of the combined assay of 3 biomarkers: α-FP, α-FP-L3 and DCP (simultaneously measured by µTASWakoTM i30 automated in vitro diagnostic system) in high-risk subjects to develop this neoplasm.
In particular, it aims to:
- Evaluate the clinical utility of the combined use of α-FP, α-FP-L3 and DCP in predicting the onset of HEPATOCARCINOMA (HCC);
- Evaluate the performance of GALAD and GALADUS scores in the early diagnosis of HCC;
- Evaluate the association between the levels of the three biomarkers (individually and in combination with each other) and the stage of HCC
详细描述
HCC occurs in 70-95% of cases in patients with chronic liver disease, rarely in a "healthy" liver. Globally about 80% of HCCs are associated with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection and their geographical distribution closely correlates with their epidemiology. Approximately 1/3 of patients with liver cirrhosis will develop HCC in the long term, with an annual risk ranging from 1%-8%.
Chronic viral hepatitis C (CHC) and chronic viral hepatitis B (CHB) together with cirrhosis of the liver respectively represent the most important risk factors in Western and Eastern Europe and therefore prolonged surveillance and prevention is recommended in these patients.
Therefore, early diagnosis of HCC is of paramount importance to prolong overall survival. Today, only about 30% of patients in Europe are diagnosed at an early stage, where curative treatments are possible.
Patients with a history of chronic liver disease are at risk of developing HCC and for this reason should undergo a screening program aimed at the early diagnosis of HCC. Asymptomatic patients but with familial predisposition on a genetic basis, according to recent international guidelines, they must be monitored periodically.
Imaging (ultrasonography, CT, and MRI), biopsy with histological examination, and blood alpha-fetoprotein measurements are used in diagnostics and staging. However, current screening/surveillance tools are not perfect.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case Group:
- •Patients with HCC first diagnosed from cirrhosis or other aetiology
- •Controls group:
- •Candidate patients for HCC surveillance, with liver cirrhosis and chronic hepatitis of any etiology without HCC seen at our institution
排除标准
- •Patients treated with Warfarin, an anticoagulant, as it can increase DCP levels in the absence of HCC, risking giving false positives
结局指标
主要结局
Biomarker dosage
时间窗: six months
Determine the GALAD alghoritm (Gender,Age, AFP-L3, AFP and Des-carboxy-prothrombin) by evaluating the values of AFP, AFP-L3, Des-carboxy-prothrombin for each patient, since the GALAD score had a high diagnostic performance as compared to each standalone markers in identifying HCC at any stage.
次要结局
未报告次要终点
研究者
Dr. Endrit Shahini
Principal Investigator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis