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Completed

NCT Number: NCT05200195

Deep Learning Model for the Prediction of Post-LT HCC Recurrence

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Liver Transplantation

Procedure

Deceased or living donor liver transplantation for the cure of hepatocellular cancer on cirrhosis

Primary outcomes

  1. Post-transplant HCC recurrence

    Time frame: 5 years from liver transplantation

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

Sponsors and collaborators

Lead sponsor

European Hepatocellular Cancer Liver Transplant Group

Other

Registry information

Official study title

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

Acronym: TRAIN-AI

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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