NCT07030842

Precision Recurrence Risk Assessment in Early-stage Hepatocellular Carcinoma

Multimodal Deep Learning Models for Predicting Recurrence Pattern in Hepatocellular Carcinoma: A Multicenter Retrospective Development and Validation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 579 (actual)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This retrospective observational study aims to evaluate whether artificial intelligence (AI) models can predict aggressive recurrence in patients who underwent liver resection for early-stage hepatocellular carcinoma (HCC). The main question it seeks to answer is: Can deep learning models combining preoperative MRI, postoperative pathology slides, and clinical data accurately identify HCC patients at high risk of aggressive recurrence after surgery? To answer this, the investigators will analyze existing medical data (preoperative MRIs, postoperative whole-slide images, and clinical records) from 579 patients across two medical centers. All data will be anonymized before analysis, and no additional interventions are required from participants. This study may help clinicians stratify high-risk patients who could benefit from closer surveillance or adjuvant therapies

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
PROCEDURE	liver resection	This is a retrospective observational study analyzing existing clinical data; no experimental interventions were administered. The study evaluates the predictive performance of two deep learning models (preoperative and postoperative) using standard-of-care medical data collected during routine clinical practice, including: Preoperative contrast-enhanced MRI scans Postoperative hematoxylin and eosin (H\&E)-stained whole slide images Clinical variables (laboratory results, pathology reports, and demographic data) All data were collected as part of standard diagnostic and treatment protocols for hepatocellular carcinoma (HCC) patients undergoing liver resection. No additional interventions or modifications to clinical care were implemented for study purposes. The artificial intelligence models were applied to previously acquired, de-identified data to predict aggressive recurrence patterns

Timeline

• Start date: 2023-08-25
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2025-06-22
• Last updated: 2025-06-29

Locations

1 site across 1 country: China