Liver Cancer Clinical Trial
Official title:
A National Registry of Patients With Hepatocellular Carcinoma
RATIONALE: Gathering health information about patients with liver cancer over time may help
doctors learn more about the disease and may help the study of cancer in the future.
PURPOSE: This clinical trial is developing a national registry and blood bank of patients
with liver cancer.
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 are 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 are collected at baseline and then every 6 months for up to 5 years. The data
are derived from investigator interviews with patients and from medical chart review of
routine medical care provided during the course of the study. Data are 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.
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Observational Model: Case-Only, Time Perspective: Cross-Sectional
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