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

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.