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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01034865

Enrollment

750

Registered

2009-12-18

Start date

2001-05-31

Completion date

2009-06-30

Last updated

2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results