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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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


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
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