Circulating MicroRNA Levels as a Predictor of Successful Bridging or Down-Staging Loco-Regional Therapy (LRT) to Liver Transplantation for Patients With Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Patient Clinical Status - Liver Transplant
研究概览
简要总结
This study investigates if an experimental blood test can help predict how well cancer will remain under control with treatment. Ther experimental blood test involves measuring mircoRNAs. MicroRNAs are small molecules which help regulate how genes are expressed. This information may help researchers guide treatment for other patients in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Definite diagnosis of hepatocellular carcinoma established (by standard radiographic or histologic criteria)
- •Felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy
排除标准
- •Either active or recent solid organ cancer other than hepatocellur carcinoma (HCC) within the last 5 years, unless determined by transplant hepatology team not to represent contra-indication to liver transplantation
- •Contra-indication to LRT (as assessed by interventional radiologist, for example severe thrombocytopenia, severe vascular disease precluding access, etc)
- •History of prior liver transplantation
- •Active or prior systemic therapy for HCC
结局指标
主要结局
Patient Clinical Status - Liver Transplant
时间窗: At study completion, up to 12 months
Undergoing liver transplant
Patient Clinical Status - Death
时间窗: At study completion, up to 12 months
Will assess the following: death
Incidence of "Wait List Drop Off"
时间窗: At study completion, up to 12 months
Will be estimated and presented with a Clopper-Pearson exact binomial confidence interval
Patient Clinical Status - Candidacy
时间窗: At study completion, up to 12 months
No longer candidate for transplantation for reasons other than tumor progression
Patient Clinical Status
时间窗: At study completion, up to 12 months
No longer candidate for transplantation due to tumor progression despite loco-regional therapy efforts
次要结局
- Clinical Status of the subset of patients successfully reaching liver transplant(At 1 year after transplantation)
- Time to "Wait List Drop Off"(Up to 12 months)