National Registry and Blood Bank of Patients With Liver Cancer

NCT00482365 | Completed DMC

• 3 other identifiers: VICC GI 0224VU-VICC-GI-0224VU-VICC-IRB-020116
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 3

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.

Conditions

Liver Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Serum repository for registry patients

  At study entry

Interventions

biologic sample preservation procedure OTHER

biologic sample preservation procedure

Also known as: blood draw and storage

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients identified as having Hepatocellular carcinoma (HCC).

You may qualify if:

• Diagnosis of hepatocellular carcinoma at a participating institution

You may not qualify if:

• None

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37067-1631, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37067, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sunil Geevarghese, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery; Director, Transplant Center Clinical Trials Office; Director, Living Donor Transplant Program; Liver and Hepatobiliary Surgeon

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: April 1, 2002
• Primary Completion: April 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 19, 2013

Record last verified: 2013-05

Locations

US (3)