Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer

NCT ID: NCT00899002

Last Updated: 2013-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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comparative genomic hybridization

Intervention Type GENETIC

molecular genetic technique

Intervention Type GENETIC

mutation analysis

Intervention Type GENETIC

polymerase chain reaction

Not noted

Intervention Type GENETIC

proteomic profiling

Intervention Type GENETIC

immunohistochemistry staining method

not noted

Intervention Type OTHER

laboratory biomarker analysis

not noted

Intervention Type OTHER

mass spectrometry

not noted

Intervention Type OTHER

medical chart review

not noted

Intervention Type OTHER

Other Intervention Names

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None specified none noted none noted none specified none noted none specified none specified none specified none specified

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Laura W. Goff, MD

Assistant Professor of Medicine, Medical Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Goff, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Other Identifiers

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VU-VICC-GI-0611

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-060479

Identifier Type: -

Identifier Source: secondary_id

VICC GI 0611

Identifier Type: -

Identifier Source: org_study_id

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