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NCT07444905

Evaluation of a Machine Learning-Based Prediction Strategy for Extrahepatic Metastasis in Hepatocellular Carcinoma

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

This is a multicenter prospective observational cohort study in patients with hepatocellular carcinoma (HCC) after curative-intent treatment. The study aims to prospectively validate previously developed machine learning-based risk stratification models for extrahepatic metastasis (with a focus on lung and bone metastasis) and to evaluate their potential clinical utility in real-world postoperative surveillance and management pathways. The study does not assign treatments or surveillance strategies to participants. Clinical care is determined by treating physicians according to local practice. The study will assess model performance (including discrimination and calibration), risk stratification ability, and implementation-related outcomes such as model adoption, decision impact, and changes in monitoring intensity or referral pathways. The study will also explore clinical and resource-related outcomes associated with model-informed risk stratification in routine practice.

Official title: Evaluating a Machine Learning-Based Strategy for Predicting Extrahepatic Metastasis and Guiding Risk-Adapted Surveillance in Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2023-01-01

Completion Date

2026-03-31

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

OTHER

Machine Learning-Based Risk Assessment

Risk stratification using a previously developed machine learning model; no treatment assignment is performed.

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China