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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT00912847
Collaborator
(none)
1,018
Enrollment
78
Duration (Months)

Study Details

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 Intervention/Treatment Phase

    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 :
    Oct 1, 1997
    Actual Primary Completion Date :
    Apr 1, 2004
    Actual Study Completion Date :
    Apr 1, 2004

    Arms and Interventions

    Arm Intervention/Treatment
    JHC

    AFP > 20 ng/ml and USG positive
    Non JHC

    patient without AFP > 20 or USG negative

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      40 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Chinese University of Hong Kong

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00912847
      Other Study ID Numbers:
      • RHCC002
      First Posted:
      Jun 3, 2009
      Last Update Posted:
      Jun 3, 2009
      Last Verified:
      Jun 1, 2009
      Keywords provided by , ,
      HBV carriers
      Additional relevant MeSH terms:
      Hepatitis B
      Carcinoma, Hepatocellular

      Study Results

      No Results Posted as of Jun 3, 2009