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

April 27, 2017 updated by: Mindie H. Nguyen, Stanford University

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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:

Patients who declined to participate in the study
Patients with a history of HIV infection
Patients with concurrent advanced malignancy of non-hepatic origin.
Patients with significant use of androgenic steroid.
Patients with exposure to vinyl chloride.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

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

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

Principal Investigator: Mindie H. Nguyen, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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