Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482365
Status:
COMPLETED
Last Update Posted:
2013-08-19
First Post:
2007-06-04
Brief Title:
National Registry and Blood Bank of Patients With Liver Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
A National Registry of Patients With Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE This clinical trial is developing a national registry and blood bank of patients with liver cancer
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 1500 patients will be accrued for the Vanderbilt University Medical Center study and up to 2000 patients for the national study
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 1500 patients will be accrued for the Vanderbilt University Medical Center study and up to 2000 patients for the national study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VU-VICC-IRB-020116 | None | None | None |
| VU-VICC-GI-0224 | None | None | None |