Clinical Study on the Combined Detection of Plasma GNB4 and Riplet Gene Methylation for Monitoring Primary Liver Cancer Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- specificity
研究概览
简要总结
Through follow-up testing of patients with primary liver cancer who underwent hepatectomy, liver transplantation, ablation therapy, or transarterial chemoembolization (TACE), a blinded comparative trial was conducted at each monitoring site. This trial evaluated the combined methylation detection kit for GNB4 and Riplet genes (fluorescent PCR method) against the clinical reference standard (defined as the physician's comprehensive diagnosis based on clinical guidelines and other criteria). The study evaluated the clinical performance of the assay in diagnosing primary liver cancer recurrence and validated the clinical efficacy of methylation detection kits for monitoring recurrence after primary liver cancer treatment.
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
- •Primary liver cancer
排除标准
- •Concurrent other malignant tumors;
- •Ineligible for hepatectomy, liver transplantation, ablation, or TACE therapy;
- •Negative methylation status prior to treatment.
研究组 & 干预措施
Primary liver cancer patients
干预措施: plasma GNB4 and Riplet genes methylation detection (Diagnostic Test)
结局指标
主要结局
specificity
时间窗: Through study completion, an average of 1 year
sensitivity
时间窗: Through study completion, an average of 1 year
次要结局
未报告次要终点
