National Registry and Blood Bank of Patients With Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00482365
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : August 19, 2013
Information provided by (Responsible Party):
Sunil K. Geevarghese, Vanderbilt-Ingram Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment
Liver Cancer Other: biologic sample preservation procedure Other: medical chart review Other: Patient interview

Detailed Description:


  • 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.

Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A National Registry of Patients With Hepatocellular Carcinoma
Study Start Date : April 2002
Actual Primary Completion Date : April 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Intervention Details:
    Other: biologic sample preservation procedure
    biologic sample preservation procedure
    Other Name: blood draw and storage
    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.

Primary Outcome Measures :
  1. Etiologic factors associated with hepatocellular carcinoma in different ethnic groups across the US [ Time Frame: every 6 months up to 5 years ]
    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.

Secondary Outcome Measures :
  1. Serum repository for registry patients [ Time Frame: At study entry ]
    blood samples will be drawn at the time of standard of care and stored.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients identified as having Hepatocellular carcinoma (HCC).

Inclusion Criteria:

  • Diagnosis of hepatocellular carcinoma at a participating institution

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00482365

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37067-1631
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37067
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Principal Investigator: Sunil Geevarghese, MD Vanderbilt-Ingram Cancer Center

Responsible Party: Sunil K. Geevarghese, Assistant Professor of Surgery; Director, Transplant Center Clinical Trials Office; Director, Living Donor Transplant Program; Liver and Hepatobiliary Surgeon, Vanderbilt-Ingram Cancer Center Identifier: NCT00482365     History of Changes
Other Study ID Numbers: VICC GI 0224
First Posted: June 5, 2007    Key Record Dates
Last Update Posted: August 19, 2013
Last Verified: May 2013

Keywords provided by Sunil K. Geevarghese, Vanderbilt-Ingram Cancer Center:
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

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases