Clinical Trial: Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Molecular Analysis of Liver Cancer

Brief Summary:

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at biomarkers in stored tumor samples from younger patients with liver cancer.


Detailed Summary:

OBJECTIVES:

  • To characterize, at a molecular level, archived samples of tissue from young patients with fibrolamellar carcinoma and hepatocellular carcinoma in non-cirrhotic livers matched for age and sex.
  • To perform genomic analysis on these tissue samples using array comparative genomic hybridization.
  • To perform targeted gene mutation analysis on these samples by PCR.
  • To perform proteomic profiling on fixed tissues in these samples by various proteomic methods, including IHC and mass spectrometry.
  • To look for association between molecular aberrations and clinicopathologic features in these samples.

OUTLINE: Archived tissue samples are collected from the pathology department at Vanderbilt University Medical Center and from the Mayo Clinic in Rochester, Minnesota. Tissue samples are analyzed by genomic analysis using array comparative genomic hybridization, target gene mutation analysis by PCR, and proteomic profiling on fixed tissues using various proteomic methods, including IHC and mass spectrometry. Samples are also examined for association between molecular aberrations and clinicopathologic features found in each disease.

Clinical patient data (i.e., age, sex, race, date of diagnosis, risk factors, histology, surgical staging, follow-ups, date of death, and adjuvant therapy) are also collected.


Sponsor: Vanderbilt-Ingram Cancer Center

Current Primary Outcome: Identification of proteomic profiles and molecular pathways involved in tumor progression [ Time Frame: After collection of tissue samples ]

Genomic analysis, targeted gene mutation analysis, immunohistochemistry, and mass spectrometry will be employed to identify proteomic profiles and specific molecular pathways involved in tumor progression of fibrolamellar carcinoma and hepatocellular carcinoma


Original Primary Outcome:

  • Discovery of specific molecular pathways involved in tumor progression
  • Discovery of specific features and molecular targets for the treatment of liver cancer


Current Secondary Outcome: Association between fibrolamellar carcinoma and hepatocellular carcinoma in terms of molecular aberrations and clinicopathologic features [ Time Frame: After molecular analysis of tissue and after collection of clinicopathologic data ]

Compare and contrast fibrolamellar carcinoma with hepatocellular carcinoma in terms of the molecular differences, tissue pathologies, and medical histories.


Original Secondary Outcome:

Information By: Vanderbilt-Ingram Cancer Center

Dates:
Date Received: May 9, 2009
Date Started: July 2007
Date Completion:
Last Updated: April 8, 2013
Last Verified: April 2013