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

NCT01034865 | Completed

• 3 other identifiers: SU-11022007-78876873HEP0009
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• For both experimental subjects and controls:
• Patients between older than 18 years of age of all ethnic backgrounds and genders.
• Patients with chronic liver disease
• For Experimental Subjects Only:
• Patients with HCC with a hepatic mass larger or equal to 5cm
• Patients with HCC with a hepatic mass lesion confirmed by fine needle aspirate (FNA) or by pathology in the cases of surgical resection
• 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 :
• \. A normal AFP level
• \. a negative imaging study (ultrasound, CT, or MR imaging).
• \. Negative liver cancer on explants.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Mindie H. Nguyen

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 18, 2009
• Study Start: May 1, 2001
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

US (1)