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

NCT06799468 | Completed

• 1 other identifier: EHCLTG
• Study Type: observational
• Target: 1,769
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

deep learning; Milan Criteria; Metroticket 2.0; AFP French Model; recurrence

Outcome Measures

Primary Outcomes (1)

• HCC recurrence

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

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

Interventions

liver transplantation PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult (\>18 years old) patients listed and transplanted with a primary diagnosis of HCC between January 2003 and December 2018

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Hepatocellular Cancer Liver Transplant Group: lead

Related Publications (1)

• Lai Q, De Stefano C, Emond J, Bhangui P, Ikegami T, Schaefer B, Hoppe-Lotichius M, Mrzljak A, Ito T, Vivarelli M, Tisone G, Agnes S, Ettorre GM, Rossi M, Tsochatzis E, Lo CM, Chen CL, Cillo U, Ravaioli M, Lerut JP; EurHeCaLT and the West-East LT Study Group. Development and validation of an artificial intelligence model for predicting post-transplant hepatocellular cancer recurrence. Cancer Commun (Lond). 2023 Dec;43(12):1381-1385. doi: 10.1002/cac2.12468. Epub 2023 Oct 30. No abstract available.

  PMID: 37904670 BACKGROUND

Related Links

• The online calculator of the score

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: January 1, 2003
• Primary Completion: January 1, 2003
• Study Completion: December 31, 2018
• Last Updated: January 29, 2025

Record last verified: 2025-01