跳至主要内容
临床试验/NCT04220151
NCT04220151Unknown不适用

Epigenetic Changes in Hepatocellular Carcinoma Developed After Direct Acting Antiviral Therapy for Chronic Hepatitis C

Assiut University0 个研究点目标入组 100 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Percentages of methylation of DNA in patients with HCC

研究概览

简要总结

Hepatocellular carcinoma (HCC) is the most common type of liver cancer, its survival rate ranks only second to lung cancer and it is a severe threat to human health.

In Egypt, HCC constitutes a significant public health problem. Where it is responsible for 33.63% and 13.54% of all cancers in males and females respectively. It has a poor prognosis after discovery, which is usually at a late stage of disease. This had been strongly linked to the hepatitis C virus epidemic that affected around 10-15% of the Egyptian population during the last 3 decades, and was reported as the highest prevalence of HCV in the world. However, the pathophysiological mechanisms involved remain unclear. The occurrence of HCC is a complicated process involving multiple genes and steps. Imbalances in cellular signal transduction pathways, deficiencies in DNA repair regulating genes, activation of protooncogenes, inactivation of tumor suppressor genes and epigenetic modifications all promote the occurrence of liver cancer.

详细描述

HCC is the fourth leading cause of cancer mortality in 2018. The alarming incidence of HCC is explained by genetic and epigenetic alterations, as well as by the presence of risk factors: hepatitis C virus (HCV), hepatitis B virus (HBV) infection, alcohol consumption, smoking, diabetes, dietary exposure to aflatoxins, and obesity.

The development of direct-acting antivirals (DAAs) with cure rates of higher than 90% has been a major breakthrough in the management of patients with chronic HCV infection. However, although viral cure decreases the overall HCC risk in HCV-infected patients, it does not eliminate virus-induced HCC risk, especially in patients with advanced fibrosis. Furthermore, convenient biomarkers to robustly predict HCC risk after viral cure and strategies for HCC prevention are absent. These unexpected findings pose new challenges for patient management. Meanwhile, recent studies in patients treated with interferone-free therapy have also identified several risk factors for developing HCC after achieving sustained virological response (SVR), namely advanced hepatic fibrosis and higher levels of alpha feto protein and agglutinin-positive Mac-2 binding protein.

Epigenetics refers to inherited altered gene expression without an alteration of the DNA sequence itself. Epigenetic alterations, such as DNA hypomethylation or hypermethylation and aberrant expression of micro-RNAs have been studied and associated with HCC. Epigenetic changes may represent diagnostic and prognostic biomarkers of HCC.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HCC treated with DAAs drugs for chronic hepatitis C in Assiut University Hospital.

排除标准

  • Cases who started treatment for HCC like alcohol ablation or chemoembolization
  • Hepatitis B infection
  • Non-responder patients to DAAs

结局指标

主要结局

Percentages of methylation of DNA in patients with HCC

时间窗: Baseline

Hypermethylation is known to be associated with decreased gene expression

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reham I El-mahdy

Principal Investigator

Assiut University

相似试验