Frequency of Circulating Tumor Cells (CTCs) and Amount of Cell-free DNA (cfDNA) in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Number of circulating tumor cells (CTCs) in cirrhotic patients with hepatocellular carcinoma (HCC)
研究概览
简要总结
All consecutive patients with liver cirrhosis, with clinical and imaging features suggestive of Hepatocellular Carcinoma (HCC) attending the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS) from February 2017 to December 2018 will be evaluated for inclusion.Based on the previous years data of HCC patients admitted to ILBS.
Cirrhotic patients aged 18-70 years, with HCC proven by typical radiological features of arterial enhancement and delayed wash-out, on one or both of dynamic Computerized Tomographic or dynamic Magnetic Resonance Imaging (MRI), as per updated American Association for the Study of Liver Disease (AASLD) guidelines (details in appendix1).
Age and gender matched patients with cirrhosis, but without HCC, seen during the same study period will serve as controls.
Patient characteristics, etiology of cirrhosis, and liver function parameters will be noted. Investigator will stage the included patients as per the Barcelona Cancer of Liver Cancer (BCLC) criteria (details in appendix1). Investigator will then estimate Circulating Tumor Cells (CTC) and cfDNA in peripheral blood samples of the patients and controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-70 years.
- •Proven cirrhosis (Defined in appendix 1).
- •HCC proven by standard radiological criteria within last 1-month (For Cases)
- •No HCC on dynamic CT and/or dynamic MRI (protocol defined in appendix 1) done within last 1 month (For Control Group).
排除标准
- •Previous biopsy or FNA of the tumor.
- •Previous invasive radiological procedures TACE/RFA.
- •Previous or ongoing chemotherapy or biological therapy.
- •Previous liver resection or transplant.
- •Segmental / main PV thrombosis.
- •Atypical enhancement on imaging
- •Extrahepatic metastatic spread of HCC
- •>70 years of age
- •Coexisting sepsis.
- •Renal dysfunction, as defined by serum creatinine >1.5mg/dL.
结局指标
主要结局
Number of circulating tumor cells (CTCs) in cirrhotic patients with hepatocellular carcinoma (HCC)
时间窗: Day 0
Number of cell-free DNA (cfDNA) in cirrhotic patients with hepatocellular carcinoma (HCC)
时间窗: Day 0
次要结局
- Number of cfDNA amount with the tumor size of HepatoCellular Carcinoma.(Day 0)
- Number of Circulatory Tumor Cells withBarcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.(Day 0)
- Number of Circulating Tumor Cells in the peripheral blood of cirrhotic patients in both groups(Day 0)
- Number of Circulatory Tumor Cells with the tumor size of HepatoCellular Carcinoma.(Day 0)
- Number of cfDNA amount with the tumor number of HepatoCellular Carcinoma.(Day 0)
- Number of Circulatory Tumor Cells with the tumor number of HepatoCellular Carcinoma.(Day 0)
- Number of cfDNA amount with the Barcelona Clinic of Liver Cancer (BCLC) stage of HepatoCellular Carcinoma.(Day 0)
- To study the difference in amount of cfDNA in the peripheral blood of cirrhotic patients with and without HCC.(Day 0)