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Validation of the TRAIN-AI for the Risk of HCC Recurrence After Liver Transplantation

NCT06799468 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1769

Last updated 2025-01-29

No results posted yet for this study

Summary

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.

Conditions

  • Hepatocellular Carcinoma (HCC)
  • Liver Transplantation
  • Deep Learning Model

Interventions

PROCEDURE

liver transplantation

Liver transplantation or hepatic transplantation is the replacement of a diseased liver with the healthy liver from another person (allograft). Liver transplantation is a treatment option for end-stage liver disease and acute liver failure, although availability of donor organs is a major limitation. Liver transplantation is highly regulated, and only performed at designated transplant medical centers by highly trained transplant physicians. Favorable outcomes require careful screening for eligible recipients, as well as a well-calibrated live or deceased donor match.

Sponsors & Collaborators

  • European Hepatocellular Cancer Liver Transplant Group

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-01
Primary Completion
2003-01-01
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06799468 on ClinicalTrials.gov