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

NCT ID: NCT00912847

Last Updated: 2009-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1018 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1997-10-31
• Study Completion Date: 2004-04-30

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.

Conditions

Hepatitis B Virus

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

JHC

AFP \> 20 ng/ml and USG positive

No interventions assigned to this group

Non JHC

patient without AFP \> 20 or USG negative

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Clinical Oncology

Other Identifiers

RHCC002

Identifier Type: -

Identifier Source: org_study_id