National Registry and Blood Bank of Patients With Liver Cancer

Liver Cancer Clinical Trial

Official title:

A National Registry of Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482365
• Other study ID #: VICC GI 0224
• Secondary ID: VU-VICC-GI-0224V
• Status: Completed
• Phase: N/A
• First received: June 4, 2007
• Last updated: August 16, 2013
• Start date: April 2002
• Est. completion date: August 2009

Study information

• Verified date: May 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: August 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of hepatocellular carcinoma at a participating institution

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serum repository for registry patients	blood samples will be drawn at the time of standard of care and stored.	At study entry	No