National Registry and Blood Bank of Patients With Liver Cancer

August 16, 2013 updated by: Sunil K. Geevarghese, Vanderbilt-Ingram Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

151

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37067-1631
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, United States, 37067
        • Vanderbilt-Ingram Cancer Center at Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients identified as having Hepatocellular carcinoma (HCC).

Description

Inclusion Criteria:

  • Diagnosis of hepatocellular carcinoma at a participating institution

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 6 months up to 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Investigators

  • Principal Investigator: Sunil Geevarghese, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

June 4, 2007

First Submitted That Met QC Criteria

June 4, 2007

First Posted (Estimate)

June 5, 2007

Study Record Updates

Last Update Posted (Estimate)

August 19, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC GI 0224
  • VU-VICC-GI-0224
  • VU-VICC-IRB-020116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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