Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer

Liver Cancer Clinical Trial

Official title:

Molecular Analysis of Liver Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00899002
• Other study ID #: VICC GI 0611
• Secondary ID: VU-VICC-GI-0611V
• Status: Withdrawn
• Phase: N/A
• First received: May 9, 2009
• Last updated: April 8, 2013
• Start date: July 2007
• Est. completion date: May 2009

Study information

• Verified date: April 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

DISEASE CHARACTERISTICS:

• Diagnosis of fibrolamellar carcinoma or hepatocellular carcinoma in a non-cirrhotic liver

• Archived tumor specimens available for analysis from Vanderbilt University or Mayo Clinic

Exclusion Criteria:

• Not specified

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Genetic:
• comparative genomic hybridization
Not specified
• molecular genetic technique
Not specified
• mutation analysis
Not specified
• polymerase chain reaction
Not noted
• proteomic profiling
not specified

Other:
• immunohistochemistry staining method
not noted
• laboratory biomarker analysis
not noted
• mass spectrometry
not noted
• medical chart review
not noted

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of proteomic profiles and molecular pathways involved in tumor progression	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	After collection of tissue samples	No
Secondary	Association between fibrolamellar carcinoma and hepatocellular carcinoma in terms of molecular aberrations and clinicopathologic features	Compare and contrast fibrolamellar carcinoma with hepatocellular carcinoma in terms of the molecular differences, tissue pathologies, and medical histories.	After molecular analysis of tissue and after collection of clinicopathologic data	No