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

Risk Factors and Molecular Genomics for Hepatocellular Carcinoma in U.S. Patients With Chronic Liver Disease: A Case Control Study

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Hepatocellular

• Study Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Mindie H. Nguyen, Stanford University

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: December 16, 2009
• First Submitted That Met QC Criteria: December 16, 2009
• First Posted (Estimate): December 18, 2009

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Neoplasms; Liver Diseases; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: SU-11022007-788; 76873; HEP0009 (Other Identifier: Stanford)