Risk Factors, Prognosis, and Potential Chemoprevention Drugs in Patients With Recurrent Hepatocellular Carcinoma After Curative Surgeries: a Nationwide Retrospective Cohort Study and a Multi-center Prospective Cohort Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Backgrounds: Surgeries are the mainstream of curative therapies for hepatocellular carcinoma (HCC). However, high risk of recurrent HCC after liver surgeries is still the unsolved clinical issue (early recurrence 21% per year; late recurrence 18% per year). Early recurrence mainly result from disseminated HCC; by contrast, late recurrence usually originate from carcinogenic microenvironment. Currently, no large-scale nationwide studies that integrate laboratory date and clinical information was performed to investigate risk factors and prognosis of post-operative recurrent HCC. Besides, owing to economic issue, few companies would initiate pharmacologic studies to investigate chemoprevention agents for HCC. Furthermore, few biomarkers were discovered from Taiwanese HCC cohort to predict post-operative tumor recurrence because of no standardized cooperative platforms to share biological tissue and clinical information. Therefore, we wish to utilize a nationwide retrospective cohort from integrated national health insurance database (NHIRD) and a prospective multi-center clinical cohort study to address aforementioned issues.
Aims:
- Investigate risk factors and prognosis of post-operative recurrent HCC in Taiwanese cohort
- Discover chemoprevention targets from generic drugs to reduce risk of post-operative recurrent HCC
- Determine biomarkers from Taiwanese cohort in prediction of post-operative recurrent HCC
详细描述
Study subject and methods:
Nationwide retrospective cohort study
- Establish prediction models for postoperative recurrent HCC by analyzing surgical HCC patients' clinical information and perioperative laboratory date based on the database of a nationwide retrospective cohort organized by the Ministry of Health and Welfare and Health insurance office
- Discover chemoprevention agents in association with reduced risk of post-operative recurrent HCC using the aforementioned database
Multicenter prospective cohort study:
- To discover biomarkers in prediction of post-operative recurrent HCC , we will establish a shared platform to prospectively and systemically collect Taiwanese HCC surgical patients' bio-materials and clinical information from China Medical University Hospital, Asian University Hospital, Mackay Hospital, Taichung Veterans General Hospital, E-Da Hospital,...etc.
- Using the multicenter prospective cohort, we could validate the results from the nationwide retrospective cohort study, and even improve the prediction models by adding biological parameters that are not available in the nationwide retrospective cohort
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All HCC surgical patients aged more than 20 year-old who sign informed consent for donating remnant tissue or blood after liver surgeries
排除标准
- •Pregnant women
结局指标
主要结局
Overall survival
时间窗: 5 year
Overall survival
Disease free survival
时间窗: 5 year
Disease free survival
次要结局
未报告次要终点
研究者
Chun Chieh Yeh
Dr.
China Medical University Hospital
