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

NCT05200195 | Completed

• 1 other identifier: #004
• Study Type: observational
• Target: 4,026
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant Disorder; Liver Cancer; Recurrent Cancer

Keywords

artificial intelligence; deep learning; mathematical model

Outcome Measures

Primary Outcomes (1)

• Post-transplant HCC recurrence

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

  5 years from liver transplantation

Study Arms (3)

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.

Procedure: Liver transplantation

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.

Procedure: Liver transplantation

Validation Cohort

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

Procedure: Liver transplantation

Interventions

Liver transplantation PROCEDURE

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

International Cohort Test Set; International Cohort Training Set; Validation Cohort

Eligibility Criteria

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

Study Population

All the consecutive adult (≥18 years) patients enlisted and transplanted with the primary diagnosis of HCC during the period 2000-2018 in the 18 centers composing the International and the Validation Cohorts

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• European Hepatocellular Cancer Liver Transplant Group: lead

Study Sites (1)

Quirino Lai

Rome, RM, 00151, Italy

Location

MeSH Terms

Conditions

Liver Neoplasms; Recurrence

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; 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 Officials

• Quirino Lai, MD PhD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 20, 2022
• Study Start: January 15, 2020
• Primary Completion: December 15, 2021
• Study Completion: March 15, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)