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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00912847
First Posted: June 3, 2009
Last Update Posted: June 3, 2009
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.
Information provided by:
Chinese University of Hong Kong
  Purpose

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
Hepatitis B Virus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma

Further study details as provided by Chinese University of Hong Kong:

Enrollment: 1018
Study Start Date: October 1997
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts
JHC
AFP > 20 ng/ml and USG positive
Non JHC
patient without AFP > 20 or USG negative

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Prof. Tony Mok, Clinical Oncology
ClinicalTrials.gov Identifier: NCT00912847     History of Changes
Other Study ID Numbers: RHCC002
First Submitted: June 1, 2009
First Posted: June 3, 2009
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