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Completed
NCT07687758
Non-Invasive Risk Stratification for Hepatocellular Carcinoma in HCV-Related Compensated Advanced Chronic Liver Disease Following Sustained Virological Response: Validation of the aMAP Score
Conditions: Hepatitis C Virus Infection, Compensated Advanced Chronic Liver Disease, Hepatocellular Carcinoma (HCC)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 571
Sponsor: Siriraj Hospital
Location: Siriraj Hospital Bangkok Bangkok
Summary
This retrospective cohort study evaluated the performance of non-invasive risk scores for predicting de novo hepatocellular carcinoma in adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response after sofosbuvir-based direct-acting antiviral therapy. Patients treated at Siriraj Hospital between 2013 and 2023 were included if they had compensated advanced chronic liver disease and documented SVR12. The study compared FIB-4, APRI, ALBI, and aMAP scores calculated at SVR12 for prediction of hepatocellular carcinoma during long-term follow-up. The primary aim was to identify a very-low-risk subgroup in whom hepatocellular carcinoma surveillance might potentially be de-escalated.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older
* Chronic hepatitis C virus infection treated with direct-acting antiviral therapy
* Documented sustained virological response at 12 weeks after treatment completion
* Evidence of compensated advanced chronic liver disease before direct-acting antiviral therapy, defined by at least one of the following: histologic F3 or F4 fibrosis, vibration-controlled transient elastography \>10 kPa, radiologic features compatible with advanced fibrosis or cirrhosis, or clinical or endoscopic evidence of portal hypertension
* Minimum follow-up of 12 months after sustained virological response
Exclusion Criteria:
* Incomplete or missing medical records precluding outcome assessment
* Known or suspected hepatocellular carcinoma before initiating direct-acting antiviral therapy
* Failure to achieve sustained virological response at 12 weeks
Source: ClinicalTrials.gov (NCT07687758). StuddyBuddy aggregates publicly available trial information.