National Registry and Blood Bank of Patients With Liver Cancer
NCT ID: NCT00482365
Last Updated: 2013-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
151 participants
OBSERVATIONAL
2002-04-30
2009-08-31
Brief Summary
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PURPOSE: This clinical trial is developing a national registry and blood bank of patients with liver cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Interventions
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biologic sample preservation procedure
biologic sample preservation procedure
medical chart review
review of patients' medical records at study entry and every 6 months
Patient interview
Elicit demographic data as well as information about personal habits such as drinking and smoking.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Sunil K. Geevarghese
Assistant Professor of Surgery; Director, Transplant Center Clinical Trials Office; Director, Living Donor Transplant Program; Liver and Hepatobiliary Surgeon
Principal Investigators
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Sunil Geevarghese, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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VU-VICC-GI-0224
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-IRB-020116
Identifier Type: -
Identifier Source: secondary_id
VICC GI 0224
Identifier Type: -
Identifier Source: org_study_id