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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01034865
First received: December 16, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition
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

blood


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)
  Eligibility

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

Criteria

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.

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

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

No publications provided

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
Liver Diseases
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on April 17, 2014