Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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.