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临床试验/NCT02587793
NCT02587793已完成不适用

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
208
试验地点
2
主要终点
survival

研究概览

简要总结

The aim of this project is to investigate whether the proliferative speeds of cultured cells using our method can be integrated into Barcelona Clinic Liver Cancer (BCLC) staging classification for the possibility of personalized treatment and prediction the outcomes in hepatocellular carcinoma (HCC) patients.

详细描述

A total of at least 150 patients will be included and followed for at least one year. The proliferative speeds of cultured cells will be classified into (a) rapid proliferation of HCC cells with or without concomitant rapid proliferation of cancer-associated fibroblasts (CAFs), (b) rapid proliferation of CAFs alone, and (c) slow proliferation three groups. The definition for the rapid proliferation of cultured cells fits at least one of the following two items: (1) growth area of cultured cells at the 15th-28th day > two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 15th-28th day > 70% growth area of the 25 cm flask. The GraphPad Prism software version 4.03 (GraphPad Software, Inc., La Jolla, CA, USA) is applied for statistical analysis. Influence of the proliferative speeds of cultured cells on survival and cancer progression will be calculated by the logrank test. The statistical significance is defined as P < 0.05.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients are proven to have HCC based on fine-needle aspiration of the tumor.
  • Patient have residual specimens obtained from fine-needle aspiration of the tumor.
  • Patients agree to participate this study after fully explanation.

排除标准

  • Patients are not proven to have HCC based on fine-needle aspiration of the tumor.
  • Patient do not have residual specimens obtained from fine-needle aspiration of the tumor.
  • Patients do not agree to participate this study after fully explanation.

结局指标

主要结局

survival

时间窗: one year

Correlation between the proliferative speeds of cultured cells and one year survival of the patients after aspiration of the tumor will be investigated.

次要结局

  • cancer progression(one year)

研究者

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

Zu-Yau Lin

Professor

Kaohsiung Medical University Chung-Ho Memorial Hospital

研究点 (2)

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