Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients (Screening HCC) (NCT07764835) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients (Screening HCC)
300 participantsStarted 2026-09-15
Plain-language summary
This prospective multicenter observational study evaluates the performance of a structured hepatocellular carcinoma (HCC) surveillance program in patients at increased risk of developing liver cancer. Participants will undergo routine surveillance with semiannual abdominal ultrasound reported using the Ultrasound Liver Imaging Reporting and Data System (US LI-RADS) and serum alpha-fetoprotein (AFP) testing as part of standard clinical care. The study aims to assess HCC detection rates, stage at diagnosis, detection of other hepatic malignancies, and the time intervals between detection, diagnosis, and treatment in a real-world setting. Approximately 300 participants will be enrolled and followed for up to 36 months.
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:
* Written informed consent.
* Age 18 years or older.
* Liver cirrhosis of any etiology.
* Chronic hepatitis B with moderate or high risk of HCC according to PAGE-B criteria.
* Non-cirrhotic chronic liver disease with increased risk for HCC, including fibrosis stage 3 or higher or metabolic dysfunction-associated steatotic liver disease (MASLD) with one or more risk factors for HCC.
* Followed at hepatology clinics within the Rede D'Or health network.
* Eligible for routine HCC surveillance with ultrasound and alpha-fetoprotein according to standard clinical practice.
Exclusion Criteria:
* Known hepatocellular carcinoma at enrollment.
* Previous diagnosis of hepatocellular carcinoma.
* Metastatic liver disease.
* Other malignant liver tumors present at enrollment.
* Clinical condition preventing routine surveillance follow-up.
* Inability to provide informed consent.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.