Prospective, Observational Study of Biomarkers in Liver Cancer - Identification of Actionable Events
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Biopsy of Liver Masses
研究概览
简要总结
To collect tumor tissue from patients with liver masses suspicious for primary liver cancer. The research biopsy will be used to identify biomarkers in future studies.
详细描述
In this study patients are referred to the Department of Radiology for an image-guided (either CT or ultrasound) core needle biopsy of a liver mass suspicious for primary liver cancer as a part their clinical care. A written informed consent will be obtained for the clinical biopsy per standard protocol. Additional core biopsy of the liver mass will be performed for research purposes at the time of the clinical care biopsy. The additional research biopsy is not mandatory and is subject to a separate written informed consent, which will be obtained prior to the clinical biopsy.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver mass suspicious for primary liver cancer with a diagnostic liver biopsy planned as a part of clinical care
- •Age ≥ 18 years.
- •ECOG performance status 0-2
- •Adequate organ and marrow function as defined below:
- •INR ≤ 1.5 platelets ≥ 70,000/mcl
- •Ability to understand and the willingness to sign a written informed consent
- •Target liver mass not subcapsular in nature as determined by the participating biopsy team
- •Child Pugh Turcotte score A or B
排除标准
- •Previous treatment for HCC
- •Any contraindication for clinical-care liver biopsy, including anti-coagulation therapy that cannot be discontinued prior to biopsy or large volume ascites
结局指标
主要结局
Biopsy of Liver Masses
时间窗: 5 years
To obtain tissue from biopsy of liver masses suspicious for primary liver cancer for use in future biomarker studies.
次要结局
未报告次要终点