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临床试验/NCT05200195
NCT05200195已完成不适用

Development and Validation of a Deep Learning Model for the Prediction of Hepatocellular Cancer Recurrence After Transplantation: The Time-Radiological Response- AlphafetoproteIN-Artificial Intelligence Model

European Hepatocellular Cancer Liver Transplant Group1 个研究点 分布在 1 个国家目标入组 4,026 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,026
试验地点
1
主要终点
Post-transplant HCC recurrence

研究概览

简要总结

Identifying patients at high risk for recurrence of hepatocellular carcinoma (HCC) after liver transplantation (LT) represents a challenging issue. The present study aims to develop and validate an accurate post-LT recurrence prediction calculator using the machine learning method.

详细描述

In 1996, the introduction of the Milan criteria (MC) strongly modified the selection process of hepatocellular cancer (HCC) patients waiting for liver transplantation (LT). Many attempts to widen MC have been proposed. Initially, exclusively morphology-based (nodules number and target lesion diameter) criteria were created. In the last years, extended criteria also based on biological parameters have been added. Among the most adopted biology-based features, the levels of different tumor markers, liver function parameters like the model for end-stage liver disease (MELD), the radiological response after neo-adjuvant therapies, and the length of waiting-time (WT) can be reported.

Unfortunately, all the proposed models showed suboptimal prediction abilities for the risk of post-LT recurrence. Such impairment was derived from the limitations of the standard statistical methods to account for many variables and their non-linear interactions. Therefore, developing a model based on Artificial Intelligence (AI) represents an attractive way to improve prediction ability.

Thus, the investigators hypothesize that an AI model focused on an accurate post-transplant HCC recurrence prediction should improve our ability to pre-operatively identify patients with different classes of risk for HCC recurrence after transplant.

This study aims to develop an AI-derived prediction model combining morphology and biology variables. A Training Set derived from an International Cohort was adopted for doing this. A Test Set derived from the same International Cohort and a Validation Cohort were adopted for the internal and external validation, respectively. A user-friendly web calculator was also developed.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive adult (≥18 years) patients enlisted and transplanted with the primary diagnosis of HCC during the period 2000-2018.

排除标准

  • Patients with HCC diagnosed only at pathological examination (incidental HCC)
  • Patients with mixed hepatocellular-cholangiocellular cancer misdiagnosed as HCC
  • Patients with cholangiocellular cancer misdiagnosed as HCC
  • Patients dying early after LT (≤ one month)

结局指标

主要结局

Post-transplant HCC recurrence

时间窗: 5 years from liver transplantation

Intra- and/or extrahepatic recidivism of HCC after liver transplantation

次要结局

未报告次要终点

研究者

发起方
European Hepatocellular Cancer Liver Transplant Group
申办方类型
Other
责任方
Principal Investigator
主要研究者

Quirino Lai

Principal Investigator

European Hepatocellular Cancer Liver Transplant Group

研究点 (1)

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