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临床试验/NCT07479264
NCT07479264已完成不适用

MRI-Based Radiomics and Machine Learning for Preoperative Assessment of Intratumoral Fibrosis and α-Smooth Muscle Actin Expression in Intrahepatic Cholangiocarcinoma

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2018年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
169
试验地点
1
主要终点
Treatment Effects

研究概览

简要总结

The aim of this observational study was to understand the prognostic imaging of the degree of intratumoral fibrosis and intratumoral α-SMA levels in patients with intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are:

Whether the degree of intratumoral fibrosis and the level of intratumoral α-SMA affect the overall survival and progression-free survival of ICC patients.

Participants will be surveyed for survival and tumor recurrence up to 5 years after surgery.

详细描述

Intrahepatic cholangiocarcinoma (ICC), which originates from the proximal secondary bile duct in the liver parenchyma (based on the direction of bile flow), is the second most common type of primary liver cancer after hepatocellular carcinoma, accounting for 10-20% of all primary liver cancers. In recent years, the incidence and mortality of ICC have been increasing in most regions of the world. α-SMA-positive CAFs in ICC may aggravate tumor progression and reduce survival time, which is a significant prognostic indicator. However, the evaluation of α-SMA expression level in previous studies mostly relied on subjective evaluation by pathologists after visual observation, and there was a lack of quantitative indicators. In addition, there are differences in the effect of intratumoral fibrosis on the prognosis of ICC, and there may be an interactive relationship between the expression of α-SMA and intratumoral fibrosis. The effect of intratumoral α-SMA expression level and fibrosis on the prognosis of ICC still deserves further exploration. Therefore, the aim of this study is to investigate the relationship between the expression level of α-SMA and the degree of fibrosis in ICC and Progression-free survival (PFS) and Overall survival (OS) by survival analysis. To determine the expression level of α-SMA and the risk degree of fibrosis in ICC.

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

性别
All
接受健康志愿者

入选标准

  • Patients who underwent radical resection of liver tumors in our center and obtained surgical specimens;
  • ICC was diagnosed by postoperative pathology

排除标准

  • Patients had received radiotherapy, chemotherapy, intervention and other treatments for liver tumors before surgery
  • The tumor sections could not be obtained due to the loss of wax blocks or most of the defects of pathological specimens
  • No upper abdominal Gd-EOB-DTPA-enhanced MRI examination in our center within one month before surgery
  • Poor image quality or incomplete image data

研究组 & 干预措施

α-SMA low-expression

干预措施: No Interventions (Other)

intratumoral high-fibrosis group

干预措施: No Interventions (Other)

intratumoral low-fibrosis group

干预措施: No Interventions (Other)

α-SMA high-expression group

干预措施: No Interventions (Other)

结局指标

主要结局

Treatment Effects

时间窗: From the time of the patient's surgery to the end of the 5-year follow-up

5-year overall survival (OS)

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu Danyang

Principal Investigator

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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