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

The Chinese University of Hong Kong

Status: Completed

Conditions: Hepatitis B Virus

Study type: Observational

Funder types: Other

Identifiers

NCT00912847

RHCC002

Details and patient eligibility

About

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.

Enrollment: 1,018 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Non-HBV related cirrhosis
• History of malignancy

Trial design

1,018 participants in 2 patient groups

JHC

Description:

AFP \> 20 ng/ml and USG positive

Non JHC

Description:

patient without AFP \> 20 or USG negative