Prospective, Observational Study of Biomarkers in Liver Cancer - Identification of Actionable Events

In this study patients are referred to the Department of Radiology for an image-guided
(either CT or ultrasound) core needle biopsy of a liver mass suspicious for primary liver
cancer as a part their clinical care. A written informed consent will be obtained for the
clinical biopsy per standard protocol. Additional core biopsy of the liver mass will be
performed for research purposes at the time of the clinical care biopsy. The additional
research biopsy is not mandatory and is subject to a separate written informed consent,
which will be obtained prior to the clinical biopsy.

Inclusion Criteria:

1. Liver mass suspicious for primary liver cancer with a diagnostic liver biopsy planned
as a part of clinical care

2. Age ≥ 18 years.

3. ECOG performance status 0-2

4. Adequate organ and marrow function as defined below:

INR ≤ 1.5 platelets ≥ 70,000/mcl

5. Ability to understand and the willingness to sign a written informed consent

6. Target liver mass not subcapsular in nature as determined by the participating biopsy
team

7. Child Pugh Turcotte score A or B

Exclusion Criteria:

1. Previous treatment for HCC

2. Any contraindication for clinical-care liver biopsy, including anti-coagulation
therapy that cannot be discontinued prior to biopsy or large volume ascites