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

Study Description
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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
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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

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


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Prof. Tony Mok, Clinical Oncology
ClinicalTrials.gov Identifier: NCT00912847    
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:
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Hepatitis B
Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hepatitis
Liver Diseases
Digestive System Diseases
 Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human