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临床试验/NCT05990959
NCT05990959招募中不适用

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

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2022年4月22日最近更新:
适应症

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:

  1. Investigate risk factors and prognosis of post-operative recurrent HCC in Taiwanese cohort
  2. Discover chemoprevention targets from generic drugs to reduce risk of post-operative recurrent HCC
  3. Determine biomarkers from Taiwanese cohort in prediction of post-operative recurrent HCC

详细描述

Study subject and methods:

Nationwide retrospective cohort study

  1. 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
  2. Discover chemoprevention agents in association with reduced risk of post-operative recurrent HCC using the aforementioned database

Multicenter prospective cohort study:

  1. 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.
  2. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chun Chieh Yeh

Dr.

China Medical University Hospital

研究点 (1)

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