Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer

April 8, 2013 updated by: Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center

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

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

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Sample collection: 20 cases of fibrolamellar carcinoma and 20 hepatocellular carcinomas.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Laura Goff, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (ESTIMATE)

May 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 8, 2013

Last Verified

April 1, 2013

More Information

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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