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

Stanford University

Status: Completed

Conditions: Carcinoma, Hepatocellular

Study type: Observational

Funder types: Other

Identifiers

NCT01034865

SU-11022007-788

76873

HEP0009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

750 participants in 2 patient groups

HCC PTS

Description:

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

Description:

Patients with chronic liver disease without evidence of HCC