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

Prior treatment

• 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.
• Prior treatment of tumor.
• 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.

Other illness

• History of liver transplant.
• Any significant non-liver-related medical condition in which expected survival is less than 1 year.
  • Controls
• History of liver transplantation.
• Any significant non-liver-related medical condition in which expected survival is less than 1 year.

Other

• Cases
• Uncontrolled ascites.
• Uncontrolled encephalopathy.
• 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.
• Uncontrolled ascites.
• Uncontrolled encephalopathy.

• Cases
• Males and females ages 18 years or older.
• 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.
• 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.
• 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.
• Child-Pugh score A-B8.
• Subject must be able to understand and provide informed consent.
  • Controls
• Males and females ages 18 or older.
• 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.
• 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:
  • Negative multiphase CT scan or MRI with contrast at screening/baseline visit, OR
  • Negative abdominal US at both screening/baseline visit AND 6-month follow-up visit, OR
  • Negative abdominal US at screening/baseline visit AND negative multiphase CT scan or MRI with contrast at 6-month or earlier follow-up visit.
• Child-Pugh score A-B8.
• Subject must be able to understand and provide informed consent.