National Registry and Blood Bank of Patients With Liver Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A National Registry of Patients With Hepatocellular Carcinoma

Conditions
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Liver Cancer

Intervention / Treatment
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* Other: biologic sample preservation procedure
* Other: medical chart review
* Other: Patient interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of hepatocellular carcinoma at a participating institution Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: biologic sample preservation procedure|biologic sample preservation procedure|
|Other: medical chart review|review of patients' medical records at study entry and every 6 months|
|Other: Patient interview|Elicit demographic data as well as information about personal habits such as drinking and smoking.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Etiologic factors associated with hepatocellular carcinoma in different ethnic groups across the US | A descriptive analysis will be done to describe the number of patients with HCC, their underlying etiology, correlation between etiology and demographic features and the outcome of various forms of therapy. Survival analysis will be done, comparing various forms of therapy while adjusting for stage of disease. | every 6 months up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum repository for registry patients | blood samples will be drawn at the time of standard of care and stored. | At study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized resectable adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer