Trial Information

A National Registry of Patients With Hepatocellular Carcinoma

OBJECTIVES:

- Evaluate etiologic factors associated with hepatocellular carcinoma (HCC) in different
ethnic groups and in different parts of the United States by developing a national
registry of HCC patients.

- Survey stage and potential treatability of HCC patients referred to Vanderbilt
University Hospital.

- Establish a serum repository for registry patients with samples to be used for future
studies of the pathogenesis of chronic liver disease and HCC and for developing better
diagnostic tests.

OUTLINE: This is a multicenter, cross-sectional database study.

Data is collected on patients diagnosed with hepatocellular carcinoma at Vanderbilt
University Medical Center and at other participating hospitals or liver transplantation
centers around the country for inclusion in a national registry of liver cancer patients.
Registry data is collected at baseline and then every 6 months for up to 5 years. The data
is derived from investigator interviews with patients and from medical chart review of
routine medical care provided during the course of the study. Data is collected from all
study sites and entered into a master database that includes information on patient
demographics; diagnoses and staging details; treatment history; results of laboratory
studies; and patient outcomes. Information derived from the registry is available to
investigators at all study sites.

Patients in the registry also undergo blood collection at baseline. Blood samples are stored
in a serum repository for evaluation in future studies related to liver disease, viral
hepatitis, and liver cancer. A biological marker that may be analyzed is squamous cell
carcinoma antigen immune complex (SCCA-IC).

PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for the Vanderbilt University
Medical Center study and up to 2,000 patients for the national study.