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

Hepatitis B Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912847
• Other study ID #: RHCC002
• Status: Completed
• Phase: N/A
• First received: June 1, 2009
• Last updated: June 1, 2009
• Start date: October 1997
• Est. completion date: April 2004

Study information

• Verified date: June 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1018
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatitis B Virus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong