Risk Factors and Molecular Genomics of U.S. Patients With Chronic Liver Disease &Hepatocellular CA

This study has been completed.
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
First received: December 16, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
To identify risk factors for the development and diagnosis of hepatocellular CA in patients with chronic hepatitis C and to use the data to ultimately develop an effective screening program.

Carcinoma, Hepatocellular

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Risk Factors and Molecular Genomics for Hepatolcellular Carcinoma in U.S. Patients With Chronic Liver Disease: A Case Control Study

Resource links provided by NLM:

Further study details as provided by Stanford University:

Biospecimen Retention:   Samples With DNA

Estimated Enrollment: 750
Study Start Date: May 2001
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

For Experimental Subjects Only:

Patients with HCC

For Controls Only:

Patients with chronic liver disease without evidence of HCC


Inclusion Criteria:*For both experimental subjects and controls:

  1. Patients between older than 18 years of age of all ethnic backgrounds and genders.
  2. Patients with chronic liver disease

For Experimental Subjects Only:

1. Patients with HCC with either: (i) a hepatic mass larger or equal to 5cm, or; (ii) a hepatic mass lesion confirmed by fine needle aspirate (FNA) or by pathology in the cases of surgical resection, or; (iii) a hepatic mass lesion with characteristic CT or MRI or angiographic appearance.

For Controls Only:

Patients with chronic liver disease without evidence of HCC confirmed by either :

  1. a normal AFP level
  2. a negative imaging study (ultrasound, CT, or MR imaging).
  3. Negative liver cancer on explants.

Exclusion Criteria:1. Patients who declined to participate in the study 2. Patients with a history of HIV infection 3. Patients with concurrent advanced malignancy of non-hepatic origin. 4. Patients with significant use of androgenic steroid. 5. Patients with exposure to vinyl chloride.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01034865

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Mindie H. Nguyen Stanford University
  More Information

Responsible Party: Mindie H. Nguyen, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01034865     History of Changes
Other Study ID Numbers: SU-11022007-788  76873  HEP0009 
Study First Received: December 16, 2009
Last Updated: December 16, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 26, 2016