- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00899002
Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer
Molecular Analysis of Liver Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Genetic: mutation analysis
- Genetic: proteomic profiling
- Genetic: comparative genomic hybridization
- Genetic: molecular genetic technique
- Genetic: polymerase chain reaction
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Other: mass spectrometry
- Other: medical chart review
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.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
After collection of tissue samples
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
After molecular analysis of tissue and after collection of clinicopathologic data
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Laura Goff, MD, Vanderbilt-Ingram Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC GI 0611
- VU-VICC-GI-0611
- VU-VICC-060479
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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