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

NCT ID: NCT05200195

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4026 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2022-03-15

Brief Summary

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.

Detailed Description

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.

Conditions

Liver Transplant Disorder; Liver Cancer; Recurrent Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

International Cohort Training Set

The Training Set of the International Cohort (N=3,670) was composed of the 80% (n=2936) HCC patients transplanted from 2000 to 2018 across 17 centers in Europe and Asia.

Liver transplantation

Intervention Type: PROCEDURE

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

International Cohort Test Set

The Test Set of the International Cohort (N=3,670) was composed of the 20% (n=734) HCC patients transplanted from 2000 to 2018 across 17 centers in Europe and Asia.

Liver transplantation

Intervention Type: PROCEDURE

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

Validation Cohort

The external Validation Cohort was composed of 356 HCC patients transplanted at the Columbia University, New York, during the period 2000-2018.

Liver transplantation

Intervention Type: PROCEDURE

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

Interventions

Liver transplantation

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

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Hepatocellular Cancer Liver Transplant Group

OTHER

Sponsor Role: lead

Responsible Party

Quirino Lai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quirino Lai, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

Quirino Lai

Rome, RM, Italy

Countries

Italy

Other Identifiers

#004

Identifier Type: -

Identifier Source: org_study_id