Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 3:57 AM
Ignite Modification Date: 2025-12-25 @ 3:57 AM
NCT ID: NCT00899002
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.
Study: NCT00899002
Study Brief:
Protocol Section: NCT00899002