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

Completed

• Conditions: Carcinoma, Hepatocellular

• Registration Number: NCT01034865
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2001-05
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-18
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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.

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States