ChiCTR1800018467尚未招募Unknown
HCC Screening Using DNA Methylation Changes in ctDNA
北京爱普迪医疗诊断技术有限公司1 个研究点 分布在 1 个国家开始时间: 2019年8月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 试验地点
- 1
- 主要终点
- Methylation level of the target genes
研究概览
简要总结
Primary objective: To develop and test non-invasive biomarkers based on methylation changes in PBMC, T-cells and circulated tumor DNA in hepatocellular carcinomas patients. Secondary objectives:
- To assess and analyze DNA methylation level of targeted CpG sites in PBMC, T-cells and circulated tumor DNA in plasma of HCC patients, chronic hepatitis patients and in healthy aged and sex matched controls.
- Determine the specificity and sensitivity of the tested biomarkers.
- Determine the methylation score of the tested biomarkers for early detection of HCC
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 90（—）
- 性别
- Male
入选标准
- •For HCC patient inclusion criteria include confirmed diagnosis of HCC by EASL-EORTC guidelines and confirmed hepatitis B diagnosis for HepB patients using AASLD practice guidelines. Healthy controls will be matched to the patient group for age, sex, smoking and alcohol consumption. Whole-blood specimens will be ideally collected before start of standard therapy.
排除标准
- •For HCC a strict exclusion criterion is cirrhosis, any other known inflammatory disease (bacterial or viral infection with the exception of hepatitis B or C, diabetes, asthma, autoimmune disease, active thyroid disease) which could alter T cells and monocytes characteristics as well as other cancers. For HepB patient exclusion criteria in addition to the above will be diagnosis of HCC or any other cancer. For healthy controls, exclusion criteria include any known inflammatory or infectious disease including HepB and HepC and any diagnosis of chronic disease, cancer, medications use, or drugs of abuse.
结局指标
主要结局
Methylation level of the target genes
次要结局
未报告次要终点
研究者
研究点 (1)
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