Extracellular RNA Markers of Liver Disease and Cancer

The goal is to identify an extracellular RNA candidate for the detection and diagnosis of
liver cancers such as hepatocellular cancer or biliary cancer, and chronic liver diseases.
The use of selected exRNA biomarkers for diagnosis of hepatocellular cancer (HCC) or biliary
tract cancers in patients with cirrhosis will be evaluated in a prospective case-control
study. The study will create a registry of patients who have chronic liver disease,
cirrhosis, liver and biliary tract cancers. A risk factor questionnaire will be administered
to facilitate identification of risk factors for development of liver cancer. Patient
information will be obtained from the medical record, and include demographics, medical
history, liver disease, smoking and alcohol history, etiology, family history, and clinical
laboratory data.

Inclusion Criteria:

- Lab results from within the previous 90 days.

- Diagnosis of HCC or biliary tract cancer

- Diagnosis of cirrhosis based on histology, imaging, or ultrasound.

- Diagnosis of a chronic liver disease without cirrhosis.

Exclusion Criteria for the HCC/biliary tract cancer group:

- Prior solid organ transplant.

- Previous cancer history with the last 5 years (excluding non-melanoma skin cancer),
participation in a treatment trial for HCC

Exclusion criteria for the cirrhosis and chronic liver disease groups:

- Prior solid organ transplant.

- Previous or current cancer history within the past 5 years (excluding non-melanoma
skin cancer).