Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer
|ClinicalTrials.gov Identifier: NCT00899002|
Recruitment Status : Withdrawn (slow accrual)
First Posted : May 12, 2009
Last Update Posted : April 10, 2013
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.
|Condition or disease||Intervention/treatment|
|Liver Cancer||Genetic: comparative genomic hybridization Genetic: molecular genetic technique Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: proteomic profiling Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: mass spectrometry Other: medical chart review|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Molecular Analysis of Liver Cancer|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Genetic: comparative genomic hybridization
- 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
- 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899002
|Study Chair:||Laura Goff, MD||Vanderbilt-Ingram Cancer Center|