Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Cases
1) Males and females ages 18 years or older.
2) Treatment-naïve HCC as defined by LI-RADS LR-5 or OPTN 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 > 2, or FIB-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:
a. Negative multiphase CT scan or MRI with contrast at screening/baseline visit, OR
b. Negative abdominal US at both screening/baseline visit AND 6-month follow-up visit, OR
c. 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 (if diagnosed with previous 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) Uncontrolled encephalopathy.
4) History of liver transplant.
5) Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment (if diagnosed with previous 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.