The Merits of Implementing microRNAs for Diagnosing Hepatocellular Carcinoma Among Hepatitis C Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Success Rate of Diagnostic Regimens in Identifying Hepatocellular Carcinoma
研究概览
简要总结
This study evaluates a target population of patients with Hepatitis C virus (HCV) infection, including those with complications like liver cirrhosis (LC) and hepatocellular carcinoma (HCC), to investigate the diagnostic utility of a specific panel of microRNAs (miRNAs). The intervention involves quantifying the plasma expression (PE) levels of MiR-21, 1246, 205, 29a-3p, and 497 via PCR and comparing them to healthy controls to determine their efficacy as biomarkers. The primary outcome is to assess the sensitivity, specificity, and overall accuracy of these miRNAs in differentiating HCC from cirrhotic and non-cirrhotic HCV cases, aiming to establish more reliable screening tools than current standard biomarkers like alpha-fetoprotein (AFP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed HCV infection.
- •Chronic uncomplicated HCV infection.
- •HCV complicated with liver cirrhosis.
- •HCV complicated with HCC on top of cirrhosis.
- •Willingness to participate and sign written informed consent.
排除标准
- •Advanced stage of hepatic cirrhosis with portal hypertension or hepatorenal failure.
- •Hepatic malignancies other than HCC.
- •Bilharzial pre-portal fibrosis.
- •Alcoholic fatty liver disease
- •hepatosteatosis.
研究组 & 干预措施
LC Group
21 patients with HCV complicated by liver cirrhosis.
干预措施: PCR (Diagnostic Test)
HCC Group
21 patients with HCV complicated by hepatocellular carcinoma.
干预措施: PCR (Diagnostic Test)
Control Group
21 healthy volunteers who passed pre-donation investigations at a Blood Bank.
干预措施: PCR (Diagnostic Test)
HCV Group
21 patients with newly diagnosed or chronic HCV infection, free of findings suggestive of cirrhosis or HCC.
干预措施: PCR (Diagnostic Test)
结局指标
主要结局
Success Rate of Diagnostic Regimens in Identifying Hepatocellular Carcinoma
时间窗: Around 3 months
iagnostic utility (sensitivity, specificity, and accuracy rate) of estimated plasma expression (PE) levels of microRNAs (specifically Mir-1246, Mir-21, and Mir-497) to distinguish HCC from LC and HCV
次要结局
- Diagnostic Performance for LC(Around 3 months)
- Biomarker Correlation(Around 3 months)
研究者
Raafat R. Mohammed
Assistant consultant of Clinical Pathology
Benha University