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Sponsored by: |
Vanderbilt-Ingram Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00482365 |
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 |
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Liver Cancer |
Procedure: biologic sample preservation procedure Procedure: medical chart review |
Study Type: | Observational |
Official Title: | A National Registry of Patients With Hepatocellular Carcinoma |
Estimated Enrollment: | 3500 |
Study Start Date: | April 2002 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, cross-sectional database study.
Data is 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 is collected at baseline and then every 6 months for up to 5 years. The data is derived from investigator interviews with patients and from medical chart review of routine medical care provided during the course of the study. Data is 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Tennessee | |
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, 37232-6838 |
Study Chair: | Ravi S. Chari, MD | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000548976, VU-VICC-GI-0224, VU-VICC-IRB-020116 |
Study First Received: | June 4, 2007 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00482365 |
Health Authority: | United States: Federal Government |
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 |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms |
Gastrointestinal Neoplasms Adenocarcinoma Recurrence Hepatocellular carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |