NCT07303712招募中不适用
Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization and Assessment of Treatment Response After Y90 Radioembolization: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Circulating Tumor Cell (CTC)
研究概览
简要总结
The purpose of this study is to determine if baseline liquid biopsy assays (CTC and cf-DNA) as well as single circulating tumor cell-DNA (sCTC DNA) dynamics in the early post-treatment period can predict subsequent treatment response to Y-90 radioembolization in patients with hepatocellular carcinoma (HCC).
详细描述
Study Aims and Objectives:
- Assess the detection rate of CTC and cfDNA-based mutations and the distribution of molecular features of HCC prior to Y90 across BCLC A-C stages.
- Determine CTC and cfDNA predictors at baseline that predict Y90 treatment response at 6-9 months.
- Determine temporal changes in CTC and cfDNA mutations from baseline over 6-9 month course post Y90.
- Determine if CTC mean distribution, sCTCDNA, and/or cfDNA mutational dynamic changes are predictive of treatment response at 6-9 months.
- Assess radiomic and liquid biopsy signatures associated with outcome
- Compare predictive outcome models using liquid biopsy data, imaging data, or a combination (multiomic data)
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
- •Age > or = 18 years
- •HCC confirmed on imaging, BCLC stage 0, A, B, or C
- •Transarterial Y90 radioembolization approved by multidisciplinary tumor board -
排除标准
- •Not eligible for Y90 procedure
- •Prior surgery or ablation on indicated tumors
- •Patient unable to complete the follow up visits required for clinical care or research -
结局指标
主要结局
Circulating Tumor Cell (CTC)
时间窗: Baseline, 1 month post treatment, 3 months post treatment, and 6 months post treatment
blood samples
CTA imaging
时间窗: Baseline, 3 months post treatment, 6 months post treatment
imaging of liver tumor
次要结局
未报告次要终点
研究者
研究点 (1)
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