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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034865
• Other study ID #: SU-11022007-788
• Secondary ID: 76873HEP0009
• Status: Completed
• Phase: N/A
• First received: December 16, 2009
• Last updated: April 27, 2017
• Start date: May 2001
• Est. completion date: June 2009

Study information

• Verified date: April 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Diseases

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States,