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

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ClinicalTrials.gov Identifier: NCT01034865
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Mindie H. Nguyen, Stanford University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
Carcinoma, Hepatocellular

Study Design
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Study Type : Observational
Actual Enrollment : 750 participants
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
Study Start Date : May 2001
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples With DNA
blood

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: December 18, 2009    Key Record Dates
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