An observational study in Hepatocellular Carcinoma, Liver Cirrhosis and Chronic Hepatitis B, sponsored by D'Or Institute for Research and Education. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by D'Or Institute for Research and Education · Observational
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.
Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and remains a leading cause of cancer-related mortality worldwide. Early detection through surveillance is associated with improved access to curative therapies and better survival outcomes. Despite international guideline recommendations, implementation of surveillance programs remains heterogeneous in routine clinical practice, and limited real-world evidence is available regarding the effectiveness of structured HCC surveillance pathways in Brazil.
This prospective multicenter observational study is designed to evaluate the performance of a structured HCC surveillance program implemented within the Rede D'Or healthcare network. The program combines standardized abdominal ultrasound reporting using the Ultrasound Liver Imaging Reporting and Data System (US LI-RADS), regular alpha-fetoprotein (AFP) assessment, dedicated training of healthcare professionals, and predefined referral pathways for diagnostic evaluation and clinical management.
The study aims to generate real-world evidence regarding the effectiveness of standardized surveillance strategies in populations at increased risk for HCC. In addition to evaluating HCC detection, the study will assess the clinical characteristics and staging patterns of diagnosed tumors, detection of other malignant liver lesions, and the efficiency of the diagnostic and treatment pathway. Special attention will be given to patients who do not fully meet traditional surveillance criteria but may still present clinically relevant risk for HCC, including individuals with advanced fibrosis and metabolic dysfunction-associated steatotic liver disease (MASLD).
No experimental interventions will be administered as part of this protocol. All surveillance procedures, diagnostic investigations, and treatment decisions will be performed according to routine clinical practice and the judgment of treating physicians. Data generated during routine care will be collected prospectively and analyzed to better understand the effectiveness of structured surveillance programs in real-world clinical settings.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 850 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →D'Or Institute for Research and Education is the lead sponsor of 42 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients at increased risk for hepatocellular carcinoma, including individuals with liver cirrhosis, chronic hepatitis B, advanced fibrosis, and metabolic dysfunction-associated steatotic liver disease who are receiving routine care within the Rede D'Or healthcare network.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult participants at increased risk of hepatocellular carcinoma, including patients with cirrhosis, chronic hepatitis B, advanced fibrosis, or metabolic dysfunction-associated steatotic liver disease, enrolled in a structured surveillance program consisting of semiannual ultrasound using US LI-RADS and alpha-fetoprotein assessment as part of routine clinical care.
Annual Incidence Rate of Hepatocellular Carcinoma
Incidence of newly diagnosed hepatocellular carcinoma among participants enrolled in the structured surveillance program
Time frame: Up to 36 months
Early-Stage HCC Detection Rate
Proportion of hepatocellular carcinoma cases diagnosed at BCLC stage 0 or A.
Time frame: Up to 36 months
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be made publicly available. The study protocol does not include a formal data-sharing plan, and participant-level data are protected by applicable privacy and data protection regulations. Any potential future requests for access to study data will be considered on a case-by-case basis by the Sponsor and Investigator, subject to ethical, legal, and regulatory requirements.
Start is estimated for Sep 2026; primary completion for Jun 2029, 33 months later.
Of 302 non-industry observational studies under Carcinoma, Hepatocellular, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 114. This study's planned 33 months is below that.
Counting every sponsor, half of 351 studies reached it within 51 months; a quarter within 32 and three quarters within 108.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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D'Or Institute for Research and Education