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

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ClinicalTrials.gov Identifier: NCT00912847
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:

Study Description
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 Design

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
Primary Completion Date : April 2004
Study Completion Date : April 2004
Groups and Cohorts

Group/Cohort
JHC
AFP > 20 ng/ml and USG positive
Non JHC
patient without AFP > 20 or USG negative


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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
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
More Information

Responsible Party: Prof. Tony Mok, Clinical Oncology
ClinicalTrials.gov 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
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis