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

NCT00912847 | Completed

• 1 other identifier: RHCC002
• Study Type: observational
• Target: 1,018
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is:

1. 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. 2.To establish the cost-effectiveness of the screening tests;
3. 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

Keywords

HBV carriers

Study Arms (2)

JHC

AFP \> 20 ng/ml and USG positive

Non JHC

patient without AFP \> 20 or USG negative

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HBV carriers between age 40 and 70 years

You may qualify if:

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

You may not qualify if:

• Non-HBV related cirrhosis
• History of malignancy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: October 1, 1997
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: June 3, 2009

Record last verified: 2009-06