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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034865
First Posted: December 18, 2009
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mindie H. Nguyen, Stanford University
  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 Hepatocellular Carcinoma in U.S. Patients With Chronic Liver Disease: A Case Control Study

Resource links provided by NLM:


Further study details as provided by Mindie H. Nguyen, Stanford University:

Biospecimen Retention:   Samples With DNA
blood

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)
Groups/Cohorts
HCC PTS
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.
LD
Patients with chronic liver disease without evidence of HCC

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 a hepatic mass larger or equal to 5cm
    2. Patients with HCC with a hepatic mass lesion confirmed by fine needle aspirate (FNA) or by pathology in the cases of surgical resection
    3. Patients with HCC with 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mindie H. Nguyen, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01034865     History of Changes
Other Study ID Numbers: SU-11022007-788
76873
HEP0009 ( Other Identifier: Stanford )
First Submitted: December 16, 2009
First Posted: December 18, 2009
Last Update Posted: May 1, 2017
Last Verified: April 2017

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