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Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study

This study is currently recruiting participants.
Verified April 2013 by Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Jung-Fa,Tsai, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00629421
First received: February 26, 2008
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

Although serum alpha-fetoprotein level and abdominal sonography are the main methods to screening hepatocellular carcinoma (HCC) in cirrhotic patients, the adequate time and methods used are not completely well-defined. This study aims to assess the better timing and methods for prospectively screening HCC in patients with cirrhosis


Condition
Cirrhosis
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • development of hepatocellular carcinoma [ Time Frame: during observation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1300
Study Start Date: January 2001
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Well-diagnosed consecutive patients with cirrhosis were enrolled through a designed questionnaire to obtain basic information about gender, age, etiology of cirrhosis, conventional liver function tests, serum AFP level, education level, substance use including smoking, alcohol drinking, betel quid chewing, history of familial HCC, etc. Then the patients was followed by periodic abdominal sonography examination and determination of AFP and liver function. If AFP elevated or liver nodule appears, effort to diagnose HCC will be performed.If HCC was performed, the survival will be followed-up.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Well-dignosed patients with cirrhosis

Criteria

Inclusion Criteria:

  • Image diagnosis or biochemical diagnosis or presence of portal hypertension

Exclusion Criteria:

  • Presence of hepatocellular carcinoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629421

Contacts
Contact: Jung-Fa Tsai, M.D., Ph.D. 886-7-3121101 ext 7475 jftsai@cc.kmu.edu.tw

Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
Principal Investigator: Jung-Fa Tsai, M.D., Ph.D.            
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Principal Investigator: Jung-Fa Tsai, M.D., Ph.D. Kaohsiung Medical University
  More Information

No publications provided

Responsible Party: Jung-Fa,Tsai, Professor of Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT00629421     History of Changes
Other Study ID Numbers: KMUH-IRB-960012
Study First Received: February 26, 2008
Last Updated: April 17, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Carcinoma
Liver Cirrhosis
Fibrosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Liver Diseases
Digestive System Diseases
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 16, 2013