Study of Blood, Urine, and Tissue Samples From Healthy Volunteers and Patients With Liver Cancer or Chronic Liver Disease

2014-08-27 03:19:12 | BioPortfolio


RATIONALE: Studying samples of blood, urine, and tissue in the laboratory from patients with cancer or chronic liver disease may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying blood, mouthwash, urine, and tissue samples from healthy volunteers and patients with liver cancer or chronic liver disease.




- Identify biomarkers related to hepatocellular carcinoma (HCC) that can be used for early diagnosis and prevention using tissue, blood, and/or urine samples from patients with HCC, patients at high risk for HCC, and healthy population-based volunteers (controls).

- Perform proteomic and metabolomic analysis of blood or urine samples from patients with HCC, patients at high risk for HCC, and healthy controls.

- Collect data from questionnaires, medical and pathology records, and the National Death Index.

- Assess biomarkers related to HCC diagnosis, prognosis, metastasis, and molecular subtypes using tissue samples (tumor and nontumor by needle biopsy) from patients with HCC.


- Perform candidate and genome-wide association studies to identify and validate genomic risk factors that are associated with HCC.

- Examine the relationship between genetic variants and morphologic, molecular, clinical, and prognostic outcome endpoints using genotype analysis of blood or mouthwash DNA and collection of data from questionnaires, medical and pathology records, and the National Death Index.

OUTLINE: Patients and healthy volunteers undergo an interview using a general questionnaire and a supplemental liver questionnaire. Healthy male volunteers also complete a supplemental prostate questionnaire. After the interview, blood and urine samples are collected. Fresh-frozen or paraffin-embedded tumor and nontumor tissue samples are also obtained from patients with hepatocellular carcinoma. Patients and healthy volunteers may be re-contacted in order to obtain additional questionnaire information and/or blood/urine samples.

Blood or mouthwash samples are used for the analysis of genotypes, single nucleotide polymorphisms, methylation status, and the measurement of cytokine and microRNA concentrations. Urine samples are used for metabolomic studies. Tissue samples are used for whole-genome gene expression analysis and the preparation of tissue arrays for immunohistochemical analysis of protein expression.

Outcome data (survival) is obtained from medical records, Veteran Administration databases, State of Maryland records, Social Security Death Index, and the National Death Index.

PROJECTED ACCRUAL: A total of 250 patients with primary hepatocellular carcinoma (HCC), 500 patients with chronic liver disease (high risk for HCC), and 500 healthy population-based volunteers (controls) will be accrued for this study.

Study Design



Liver Cancer


DNA methylation analysis, gene expression analysis, microarray analysis, polymorphism analysis, protein expression analysis, proteomic profiling, immunohistochemistry staining method, laboratory biomarker analysis, medical chart review, questionnaire admi


Not yet recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:19:12-0400

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