Quirino Lai
Rome, RM, 00151, Italy
NCT Number: NCT05200195
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Rome, RM, 00151, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Deceased or living donor liver transplantation for the cure of hepatocellular cancer on cirrhosis
Time frame: 5 years from liver transplantation
Intra- and/or extrahepatic recidivism of HCC after liver transplantation
European Hepatocellular Cancer Liver Transplant Group
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT04576572
Adenocarcinoma, Advanced Adult Hepatocellular Carcinoma
Malatya, Battalgazi, Turkey (Türkiye)
View Trial DetailsNCT04186234
Digestive System Diseases, Digestive System Neoplasms
Hong Kong
View Trial DetailsNCT05750329
Digestive System Diseases, Digestive System Neoplasms
View Trial DetailsNCT06563570
Liver Transplant Disorder
Izmir, İzmir, Turkey (Türkiye)
View Trial Details