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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-05-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

LD

Patients with chronic liver disease without evidence of HCC

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No