Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer

This study has been withdrawn prior to enrollment.
(slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00899002
First received: May 9, 2009
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Liver Cancer
Genetic: comparative genomic hybridization
Genetic: molecular genetic technique
Genetic: mutation analysis
Genetic: polymerase chain reaction
Genetic: proteomic profiling
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: mass spectrometry
Other: medical chart review

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Molecular Analysis of Liver Cancer

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Identification of proteomic profiles and molecular pathways involved in tumor progression [ Time Frame: After collection of tissue samples ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Compare and contrast fibrolamellar carcinoma with hepatocellular carcinoma in terms of the molecular differences, tissue pathologies, and medical histories.


Biospecimen Retention:   Samples With DNA

DNA will be extracted from the tissue samples and analyzed for molecular signatures, i.e., genomic and proteomic analyses.


Enrollment: 0
Study Start Date: July 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Genetic: comparative genomic hybridization
    Not specified
    Other Name: None specified
    Genetic: molecular genetic technique
    Not specified
    Other Name: none noted
    Genetic: mutation analysis
    Not specified
    Other Name: none noted
    Genetic: polymerase chain reaction
    Not noted
    Other Name: none specified
    Genetic: proteomic profiling
    not specified
    Other Name: none noted
    Other: immunohistochemistry staining method
    not noted
    Other Name: none specified
    Other: laboratory biomarker analysis
    not noted
    Other Name: none specified
    Other: mass spectrometry
    not noted
    Other Name: none specified
    Other: medical chart review
    not noted
    Other Name: none specified
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899002

Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Laura Goff, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Laura W. Goff, MD, Assistant Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00899002     History of Changes
Other Study ID Numbers: VICC GI 0611, VU-VICC-GI-0611, VU-VICC-060479
Study First Received: May 9, 2009
Last Updated: April 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
childhood hepatocellular carcinoma
childhood liver cancer
adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on August 28, 2014