National Registry and Blood Bank of Patients With Liver Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunil K. Geevarghese, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00482365
First received: June 4, 2007
Last updated: August 16, 2013
Last verified: May 2013
  Purpose

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 Intervention
Liver Cancer
Other: biologic sample preservation procedure
Other: medical chart review
Other: Patient interview

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A National Registry of Patients With Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Etiologic factors associated with hepatocellular carcinoma in different ethnic groups across the US [ Time Frame: every 6 months up to 5 years ] [ Designated as safety issue: No ]
    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:
  • Serum repository for registry patients [ Time Frame: At study entry ] [ Designated as safety issue: No ]
    blood samples will be drawn at the time of standard of care and stored.


Enrollment: 151
Study Start Date: April 2002
Study Completion Date: August 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients identified as having Hepatocellular carcinoma (HCC).

Criteria

Inclusion Criteria:

  • Diagnosis of hepatocellular carcinoma at a participating institution

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482365

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

No publications provided

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
ClinicalTrials.gov Identifier: NCT00482365     History of Changes
Other Study ID Numbers: VICC GI 0224, VU-VICC-GI-0224, VU-VICC-IRB-020116
Study First Received: June 4, 2007
Last Updated: August 16, 2013
Health Authority: United States: Federal Government

Keywords provided by 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
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 21, 2014