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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00912847
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : June 3, 2009
Information provided by:
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.

Condition or disease
Hepatitis B Virus

Study Type : Observational
Actual Enrollment : 1018 participants
Time Perspective: Prospective
Official Title: Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma
Study Start Date : October 1997
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

AFP > 20 ng/ml and USG positive
patient without AFP > 20 or USG negative

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HBV carriers between age 40 and 70 years

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

Responsible Party: Prof. Tony Mok, Clinical Oncology Identifier: NCT00912847     History of Changes
Other Study ID Numbers: RHCC002
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009

Keywords provided by Chinese University of Hong Kong:
HBV carriers

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Hepatitis B
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human