Study of Clinical and Laboratory Predictors of Hepatocellular Carcinoma in Post-HCV Cirrhotic Patients After Sustained Virologic Response.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- occurrence of hepatocellular carcinoma (HCC)
研究概览
简要总结
This study aims to identify clinical and laboratory factors that predict the occurrence of hepatocellular carcinoma (HCC) in Egyptian cirrhotic patients after achieving a sustained virologic response (SVR) to hepatitis C virus (HCV) treatment. This is a retrospective, two-center, case-control study that will include 132 cases and 264 controls. Variables to be analyzed include demographics, liver disease status, metabolic comorbidities, lifestyle factors, medications, as well as laboratory parameters and non-invasive scoring systems.
详细描述
Introduction:
Hepatocellular carcinoma (HCC) is a highly fatal cancer with a global 5-year survival rate of less than 20%. In Egypt, HCC is the most common cancer in men and the leading cause of cancer-related death, primarily due to the historically high prevalence of Hepatitis C Virus (HCV). While sustained virologic response (SVR) after direct-acting antiviral (DAA) therapy significantly reduces the risk of HCC, it can still occur, especially in patients with advanced fibrosis or cirrhosis. This necessitates continued HCC surveillance post-HCV cure.
Aim of Work:
To study various clinical and laboratory predictors of hepatocellular carcinoma in Egyptian cirrhotic patients after achieving sustained virologic response.
Methodology:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •for cases:
- •age ≥ 18 y;
- •HCV related cirrhosis;
- •SVR12 after DAA;
- •radiologic or histologic HCC diagnosis ≤30 Jun 2025
- •for controls: As above plus, ≥36 months post SVR without HCC
排除标准
- •for cases:
- •non HCV cirrhosis or combined HCV-HBV cirrhosis;
- •HCC <6 months before SVR;
- •concomitant cholangiocarcinoma
- •for controls: Same as cases, plus, loss to follow up before 36 months
结局指标
主要结局
occurrence of hepatocellular carcinoma (HCC)
时间窗: from SVR12 achievement to 6-9 years later (time of data collection)
measure occurrence of HCC in post-HCV liver cirrhosis after achieving SVR, by comparing cases to controls
次要结局
未报告次要终点
研究者
Zakaria Saeed Gerges Awad
Internal Medicine Resident Doctor
Sohag University