Diagnostic Accuracy of Serum Visfatin and Serum Vaspin in Patients With Hepatocellular Carcinoma on Top of Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- serum Visfatin & serum Vaspin levels
研究概览
简要总结
Hepatocellular carcinoma (HCC) has a global importance due to its high rate of progression and high mortality rates. Significant risk factors for the development of HCC are metabolic syndrome, obesity and type 2 diabetes mellitus(T2DM). Dysregulation of adipose tissue derived hormones(adipocytokines/adipokines) might also be involved in obesity-related liver carcinogenesis & due to the wide spectrum of visfatin and vaspin activities ,we focus in this study on their potential role in patients with HCV-related liver cirrhosis with and without HCC on top.
详细描述
Despite improvements in HCC therapy, the prognosis for HCC patients remains poor due to a high incidence of recurrence. Early diagnosis can significantly improve the overall survival of HCC patients. However, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker alpha-fetoprotein (AFP) has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC.
As such, AFP has been excluded from being a marker for the diagnosis of HCC by Practice Guidelines of the American Association for the study of Liver Diseases (AASLD) and confirmed by other studies.
These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. An improved understanding of the pathogenesis of HCC development would facilitate the development of more effective outcomes for the diagnosis and treatment of HCC at earlier stages.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The diagnosis of CHC will be based on positive HCV antibodies by enzyme-linked immunosorbent assay(ELIZA)& HCV RNA by Polymerase chain reaction ( PCR) for more than 6 months. The diagnosis of liver cirrhosis will be based on clinical data and findings on abdominal ultrasound. The diagnosis of HCC will be based on the typical features of dynamic imaging by triphasic CT with or without elevated serum alpha-fetoprotein (AFP) .
排除标准
- •- Co-infection with HBV.
- •Presence of clinically suspected other causes of hepatocellular injury ( any history of alcoholism, autoimmune hepatitis, primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Wilson's disease, fatty liver disases with metabolic syndrome &drug induced liver disease.
- •Patients diagnosed with other malignancies.
- •Patients with history of prior local or systemic HCC-specific treatment.
结局指标
主要结局
serum Visfatin & serum Vaspin levels
时间窗: they are measured once in all groups then compared after collection of samples, this will be in average 1.5 years
The 2 markers will be measured in the 3 groups , compared with each one \& asses if they are valuable as diagnostic markers for HCC , staging HCC , chronic liver diseases \& Metabolic disorders.
次要结局
未报告次要终点
研究者
Walaa Abdel Hamed Ali
Diagnostic Accuracy of Serum Visfatin and Serum Vaspin in Patients with Hepatocellular Carcinoma on Top of Liver Cirrhosis
Sohag University