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| ID | Type | Description | Link |
|---|---|---|---|
| VU-VICC-GI-0224 | |||
| VU-VICC-IRB-020116 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biologic sample preservation procedure | Other | biologic sample preservation procedure |
| |
| medical chart review | Other | review of patients' medical records at study entry and every 6 months | ||
| Patient interview | Other | Elicit demographic data as well as information about personal habits such as drinking and smoking. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum repository for registry patients | blood samples will be drawn at the time of standard of care and stored. | At study entry |
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Inclusion Criteria:
Exclusion Criteria:
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Patients identified as having Hepatocellular carcinoma (HCC).
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Geevarghese, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37067-1631 | United States | ||
| Vanderbilt-Ingram Cancer Center at Franklin |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Nashville |
| Tennessee |
| 37067 |
| United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |