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Prospective Evaluation of a Locked Risk-Stratified Surveillance Strategy for Extrahepatic Metastasis in Hepatocellular Carcinoma

NCT07444905 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1523

Last updated 2026-04-24

No results posted yet for this study

Summary

This is a multicenter prospective observational cohort study in adults with hepatocellular carcinoma (HCC) without baseline extrahepatic metastasis who are receiving routine clinical management and follow-up at participating centers. The study evaluates the real-world implementation and clinical utility of a locked machine learning-guided risk stratification strategy for predicting lung and bone metastasis and supporting risk-stratified surveillance. The locked strategy uses prespecified 12-month risk thresholds and linked care pathways and is implemented without retraining or threshold revision. No study-mandated treatment or surveillance assignment is performed; clinical care remains at physician discretion according to local practice. The study assesses model transportability and calibration, implementation outcomes (including completion of prespecified actions, timeliness of action, and treatment activation), clinically actionable detection outcomes, patient-important outcomes, and longer-term survival. Comparative analyses use centre- and calendar-epoch-aligned usual-care episodes as the primary observational comparator.

Conditions

  • HCC - Hepatocellular Carcinoma
  • Machine Learning
  • Evaluation

Interventions

OTHER

Machine Learning-Based Risk Assessment

Point-of-care use of a locked machine learning-guided risk assessment tool with fixed thresholds and linked risk-stratified surveillance recommendations; no study-mandated treatment assignment is performed

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Zhao Huang · Tongji Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2026-12-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07444905 on ClinicalTrials.gov