Development of a miRNA based screening assay for Hepatitis B virus (HBV) associated Hepatocellular Carcinoma (HCC).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Our study will become a platform for developing highly specific multiple microRNA based screening assay for other cancers like HPV associated oropharyngeal and anal cancers for which there does not exist a recommended screening tool.
研究概览
简要总结
Serum samples will be collected from study participants attending Gastroenterology OPD at Kasturba Medical College, a tertiary care hospital under Manipal Academy of Higher Education (MAHE). Formalin-fixed, paraffin-embedded tissue (FFPE) samples of hepatocellular carcinoma will also be procured from Department of Pathology. Virology workup will be carried out at the Manipal Institute of Virology under the Manipal Academy of Higher Education (MAHE). We will be screening serum samples of HBV positive carriers (controls), HBV positive cirrhosis and hepatocellular carcinoma cases with HBV positivity (Anti HBcAg positive) or without HBV association for 13 microRNAs (let-7e, miR-15a, miR-16, miR-21, miR-26b, miR-29b-3p, miR-126, miR-142-3p, miR-146b, miR-193a-5p, miR122, miR223, miR-192).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Chronic hepatitis B positive (HBsAg/Anti HBc IgG) with no radiological evidence of liver fibrosis.
- •Chronic hepatitis B positive liver cirrhosis cases diagnosed with upper GI endoscopic data of esophageal/gastric varices, portal hypertension or radiological features.
- •Anti-HBc IgG positive Hepatocellular carcinoma cases will be identified by ultrasonography or with or without histological evidence.
- •Anti-HBc IgG negative hepatocellular carcinoma cases diagnosed by ultrasonography with or without histological evidence.
- •Normal healthy controls.
排除标准
- •Patients with other liver diseases, pregnant women, individuals below 18 years of age, co-infection with HIV, Hepatitis C virus (HCV), serious concurrent medical illnesses like malignancy and uncontrolled diabetes mellitus will be excluded.
结局指标
主要结局
Our study will become a platform for developing highly specific multiple microRNA based screening assay for other cancers like HPV associated oropharyngeal and anal cancers for which there does not exist a recommended screening tool.
时间窗: 2 years
次要结局
- Tumour specific miRNA targets will facilitate drug development leading to precision medicine with minimal side effects(2 years)