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临床试验/NCT07466602
NCT07466602招募中不适用

Clinical Study on the Combined Detection of Plasma GNB4 and Riplet Gene Methylation for Monitoring Primary Liver Cancer Recurrence

Wuhan Ammunition Life-tech Co., Ltd1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年9月2日最近更新:
干预措施

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

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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