Proof-of-Concept Case-Control Study for Hepatocellular Carcinoma Identification Using Delta-HLD Technology (HIDE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of delta-HLD Technology
研究概览
简要总结
HIDE (Hepatocellular Carcinoma Identification via Delta-HLD) is a proof-of-concept case-control study designed to evaluate the performance of delta-HLD, Epiliquid's proprietary liquid biopsy technology, in detecting hepatocellular carcinoma (HCC). The study includes both plasma and tissue samples to assess biomarker concordance and evaluate diagnostic sensitivity and specificity using tumor-specific methylation markers detected by PCR.
详细描述
This observational case-control study aims to validate a set of methylation-based biomarkers for HCC detection using delta-HLD technology, which combines enzymatic pre-treatment and multiplexed PCR detection. Epiliquid's proprietary platform also integrates a bioinformatic system that identifies and ranks tumor-specific methylation biomarkers. The study will enroll two groups: patients with histologically confirmed HCC (cases) and patients with liver cirrhosis without evidence of cancer (controls). Liver tissue and blood samples (cfDNA) will be analyzed to assess the sensitivity, specificity, and plasma-tissue concordance of the selected epigenetic signature.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed HCC (cases) or clinically confirmed liver cirrhosis without HCC (controls)
- •Willing and able to provide informed consent
- •Available paired plasma and liver tissue sample
排除标准
- •Other active cancers
- •Prior liver transplantation
- •Known hereditary cancer syndromes
- •Recent chemotherapy or antiviral treatment (<3 months)
结局指标
主要结局
Sensitivity and Specificity of delta-HLD Technology
时间窗: Within 3 months
Diagnostic performance of delta-HLD-detected methylation biomarkers in plasma and tissue, using clinical diagnosis of HCC (confirmed by histopathology) as the reference standard.
次要结局
未报告次要终点