Clinical trial NCT00899002: Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer
Official title: Molecular Analysis of Liver Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Liver Cancer
Keywords: childhood hepatocellular carcinoma
childhood liver cancer
adult primary liver cancer
adult primary hepatocellular carcinoma
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sample collection: 20 cases of fibrolamellar carcinoma and 20 hepatocellular carcinomas.

Brief 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.

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 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

Primary outcomes:
measure: Identification of proteomic profiles and molecular pathways involved in tumor progression
timeFrame: After collection of tissue samples
Secondary outcomes:
measure: Association between fibrolamellar carcinoma and hepatocellular carcinoma in terms of molecular aberrations and clinicopathologic features
timeFrame: After molecular analysis of tissue and after collection of clinicopathologic data
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Laura Goff, MD
role: STUDY_CHAIR
References: