Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma

Completed

• Conditions: Hepatitis B Virus

• Registration Number: NCT00912847
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The purpose of this study is:

1. To establish and compare the diagnostic utilities for hepatocellular carcinoma (HCC) screening tests of (a) HS-AFP, (b) AFP + US,(c) AFP alone and (d) US alone (within HBV carriers between age 40 and 70 years);

2. To establish the cost-effectiveness of the screening tests;

3. To compare tumor sizes, resection rates, and survival rates up to 18 months between those who were screened by HS-AFP those of a historical control group that was not screened.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-10
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Status Verified: 2009-06
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-01
• Last Update Submitted: 2009-06-01
• Study First Posted: 2009-06-03
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1018

Inclusion Criteria

• Age between 40 and 70 years
• Seropositive for HBsAg
• Child's A or B
• Life expectancy of more than 2 years

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Exclusion Criteria

• Non-HBV related cirrhosis
• History of malignancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified