Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT00899002
Status:
WITHDRAWN
Last Update Posted:
2013-04-10
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
Molecular Analysis of Liver Cancer
Status:
WITHDRAWN
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
PURPOSE: This laboratory study is looking at biomarkers in stored tumor samples from younger patients with liver cancer.
Detailed Description:
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.
* 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 Oversight
Has Oversight DMC:
True
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?: