Case-Control Study of the Glycotest™ HCC Panel Vs AFP for the Detection of Early-stage Hepatocellular Carcinoma

Inclusion Criteria

• Inclusion Criteria: Cases 1. Males and females ages 18 years or older. 2. Treatment-naïve HCC as defined by LI-RADS (Liver Imaging Reporting and Data System) LR-5 or OPTN (Organ Procurement and Transplantation Network) 5 CT or MRI criteria (all lesions must exhibit arterial phase hyper-enhancement), or histologic evidence. 3. Early-stage HCC defined by single lesion ≤ 5 cm or ≤ 3 lesions ≤ 3 cm determined at enrollment or within 100 days prior without vascular invasion. 4. Cirrhosis based on serum biomarkers (FibroSure®/FibroTest > 0.74, APRI (AST to Platelet Ratio Index) > 2, or FIB-4 (Fibrosis-4) > 3.25), histology, imaging, elastography, or clinical evidence of portal hypertension in the setting of known chronic liver disease. 5. Child-Pugh score A-B8. 6. Subject must be able to understand and provide informed consent. Controls 1. Males and females ages 18 or older. 2. Cirrhosis based on serum biomarkers (FibroSure®/FibroTest > 0.74, APRI > 2, or FIB-4 > 3.25), histology, imaging, elastography, or clinical evidence of portal hypertension in the setting of known chronic liver disease. 3. Evidence of the absence of a solid hepatic mass, suspicious for HCC, at enrollment or within 100 days prior based on one of the following: 1. Negative multiphase CT scan or MRI with contrast at screening/baseline visit, OR 2. Negative abdominal US at both screening/baseline visit AND 6-month follow-up visit, OR 3. Negative abdominal US at screening/baseline visit AND negative multiphase CT scan or MRI with contrast at 6-month or earlier follow-up visit. 4. Child-Pugh score A-B8. 5. Subject must be able to understand and provide informed consent. Exclusion Criteria: Cases 1. Uncontrolled ascites. 2. Uncontrolled encephalopathy. 3. History of liver transplant. 4. Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment, including mixed HCC-CCA (cholangiocarcinoma). If previously diagnosed with malignancy, subject must be in remission for at least 5 years prior to enrollment. Prior history of HCC, including resection of HCC at any time, is excluded. 5. Prior treatment of tumor. 6. Any significant non-liver-related medical condition in which expected survival is less than 1 year. Controls 1. Imaging evidence of solid hepatic mass, suspicious for HCC, including lesions meeting LI-RADS LR-3 or LR-4, OPTN-3 or OPTN-4, or LI-RADS LR-M criteria. 2. Uncontrolled ascites. 3. History of liver transplantation. 4. Uncontrolled encephalopathy. 5. Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment (if previously diagnosed with malignancy, subject must be in remission for at least 5 years prior to enrollment). History of HCC including resection of HCC at any time, is excluded. 6. Any significant non-liver-related medical condition in which expected survival is less than 1 year.