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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00912847
First received: June 1, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof. Tony Mok, Clinical Oncology
ClinicalTrials.gov Identifier: NCT00912847     History of Changes
Other Study ID Numbers: RHCC002
Study First Received: June 1, 2009
Last Updated: June 1, 2009
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
HBV carriers

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

ClinicalTrials.gov processed this record on October 20, 2014