Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer Development
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Difference in antibody profile between subjects with chronic HCV infection receiving or not receiving DAA therapy
研究概览
简要总结
Hepatitis C virus (HCV), which infects more than 185 million people, is a major risk factor. Direct-acting antiviral (DAA) therapy has significantly improved the eradication of the virus, but has not completely eliminated the risk of HCC, so careful surveillance is necessary. The genetic diversity of the natural killer receptor, histocompatibility antigens (HLA) and interferon lambda 4 (INFL4) activity, among other factors, have been found to be crucial in directing disease progression. Importantly, these markers are detectable years before the diagnosis of HCC. In addition, polymorphic variants attributable to the expression of genes involved in innate-type immune response, such as IFNL4 and HLA-E, have been shown to be predictive for the development of HCC and have not yet been extensively studied. The aim of the study is to evaluate novel circulating biomarkers, including the presence of antibodies to specific HCV proteome peptides, IFNL4 expression, and the interaction of specific HLA receptors/ligands in a large cohort of HCV-positive subjects in order to create a screening strategy for the early diagnosis of HCV-associated HCC.
Part of the study will be devoted to describing the immune microenvironment associated with the expression of IFNL4 and HLAE, evaluating them as potential prognostic indicators for HCC in HCV-infected subjects undergoing surgery for HCC, as well as in those with advanced/metastatic HCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients aged ≥18 years with the presence of chronic infection, fibrosis, cirrhosis or HCV- associated HCC
- •Patients able to understand and willing to sign the of informed consent
- •Patients to answer the questions in the questionnaire of enrollment
排除标准
- •Treatment for other oncological diseases
- •Immunodepression congenital or acquired (HIV, organ transplantation, pharmacological)
结局指标
主要结局
Difference in antibody profile between subjects with chronic HCV infection receiving or not receiving DAA therapy
时间窗: up to 2 years
Mean or median difference between the groups, as appropriate, will be calculated
Difference in antibody profile between subjects with and without chronic HCV infection
时间窗: up to 2 years
Mean or median difference between the groups, as appropriate, will be calculated
次要结局
- Define a relationship between IgG levels toward HCV-specific peptides and viral load/development clinical after 2 years of follow-up(up to 2 years)
- Define a relationship between IgG levels toward HCV-specific peptides and HCV genotype(up to 2 years)
- Characterization of Interferon Lambda 4 (INFL4) and Human Leukocyte antigene (HLA-E) variants within patient with or without HCV related hepatocarcinoma (HCC)(up to 2 years)
- Characterization of INFL4 and HLA-E variants within patient with or without HCV related chronic hepatitis(up to 2 years)
- Define the mRNA pathways activated in the subjects with expression of INFL4 and of HLA-E(up to 2 years)