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临床试验/NCT06799468
NCT06799468已完成不适用

Validation of the TRAIN-AI Score for the Prediction of Hepatocellular Carcinoma Recurrence After Liver Transplantation

European Hepatocellular Cancer Liver Transplant Group0 个研究点目标入组 1,769 人开始时间: 2003年1月1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
1,769
主要终点
HCC recurrence

研究概览

简要总结

Liver transplantation (LT) is the best treatment option for patients with early stages of hepatocellular carcinoma (HCC).1 However, the use of LT depends on maintaining a balance between the risk of post-transplant recurrence or HCC-related death and the equitable distribution of organ donors.2-5 Current selection criteria aim to avoid transplant futility by excluding patients from LT who are at a high risk of tumor recurrence. Selecting patients within the Milan criteria has been shown to provide excellent patient outcomes.6,7 However, these criteria have been challenged by other series showing equivalent outcomes for patients transplanted with a greater tumor burden. A combination of morphologic (i.e., tumor number and size) and biological features has been recently proposed with the intent to implement the patient selection process.8,9 Machine learning represents a statistical tool that can leverage the prognostic abilities of a many clinically available variables. Recently, the TRAIN-AI has been proposed, and a post-transplant HCC recurrence risk calculator using machine learning based on the TRAIN-AI score is available.10 We are seeking to explore the generalizability of this machine learning model to other institutions through a validation study.

详细描述

Liver transplantation (LT) is the best treatment option for patients with early stages of hepatocellular carcinoma (HCC).1 However, the use of LT depends on maintaining a balance between the risk of post-transplant recurrence or HCC-related death and the equitable distribution of organ donors.2-5 Current selection criteria aim to avoid transplant futility by excluding patients from LT who are at a high risk of tumor recurrence. Selecting patients within the Milan criteria has been shown to provide excellent patient outcomes.6,7 However, these criteria have been challenged by other series showing equivalent outcomes for patients transplanted with a greater tumor burden. A combination of morphologic (i.e., tumor number and size) and biological features has been recently proposed with the intent to implement the patient selection process.8,9 Machine learning represents a statistical tool that can leverage the prognostic abilities of a many clinically available variables. Recently, the TRAIN-AI has been proposed, and a post-transplant HCC recurrence risk calculator using machine learning based on the TRAIN-AI score is available.10 We are seeking to explore the generalizability of this machine learning model to other institutions through a validation study.

Study aims and objective:

The primary objective of this study will be to validate our previously reported TRAIN-AI score using external datasets from other HCC centers.

Study design and methodology:

Validate the TRAIN-AI model by comparing it to other available recurrence risk algorithms on a held-out test set. TRAIN-AI will be compared with Milan Criteria, San Francisco Criteria, Up-to-Seven Criteria, TBS, Metroticket 2.0 Score, HALT-HCC Score, AFP-French model, 5-5-500 Role, NYCA Score, and TRAIN Score.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Eligible participants were adult patients listed and transplanted with a primary diagnosis of HCC between January 2003 and December 2018.

排除标准

  • •incidentally discovered HCC in the explanted liver;
  • •retransplantation or multivisceral transplantation;
  • •tumors misclassified as HCC on radiological assessment (e.g., cholangiocarcinoma, mixed HCC-cholangiocarcinoma);
  • •incomplete data for calculating the TRAIN-AI score.

结局指标

主要结局

HCC recurrence

时间窗: The final follow-up date was December 31, 2023.

HCC recurrence was defined as any hepatic or extra-hepatic tumor reappearance after LT, with recurrence time calculated from LT to detection.

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

Associate Professor

European Hepatocellular Cancer Liver Transplant Group

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