Non-Invasive Risk Stratification for Hepatocellular Carcinoma in HCV-Related Compensated Advanced… (NCT07687758) | Clinical Trial Compass
CompletedNot Applicable
Non-Invasive Risk Stratification for Hepatocellular Carcinoma in HCV-Related Compensated Advanced Chronic Liver Disease Following Sustained Virological Response: Validation of the aMAP Score
Thailand571 participantsStarted 2013-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has already been completed — does that mean results are available, and if so, could you walk me through what the aMAP score showed about predicting liver cancer risk in people like me who've cleared hepatitis C?
2Since this study focused specifically on people with compensated advanced chronic liver disease who achieved a sustained virological response after HCV treatment, does my current liver status and treatment history match that profile closely enough for the findings to be relevant to my situation?
3The trial was testing a non-invasive scoring tool to stratify who is at higher risk of developing hepatocellular carcinoma — could we use the aMAP score in my care today, and would it change how often I get surveillance imaging or blood tests?
4Even after successfully clearing hepatitis C, this study was tracking new cases of liver cancer — should I still be regularly screened for hepatocellular carcinoma, and how does clearing the virus actually affect my ongoing risk?
5Are there other validated risk stratification tools or surveillance protocols you already use in your practice, and how does the aMAP score compare to what you'd currently recommend for someone in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Development of de novo hepatocellular carcinoma
Timeframe: From SVR12 until diagnosis of hepatocellular carcinoma, last follow-up, or up to 8 years after SVR12.