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

February 26, 2008
April 17, 2013
January 2001
December 2013   (final data collection date for primary outcome measure)
development of hepatocellular carcinoma [ Time Frame: during observation ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00629421 on ClinicalTrials.gov Archive Site
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Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study
Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Well-dignosed patients with cirrhosis

  • Cirrhosis
  • Hepatocellular Carcinoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1300
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Image diagnosis or biochemical diagnosis or presence of portal hypertension

Exclusion Criteria:

  • Presence of hepatocellular carcinoma
Both
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No
Contact: Jung-Fa Tsai, M.D., Ph.D. 886-7-3121101 ext 7475 jftsai@cc.kmu.edu.tw
Taiwan
 
NCT00629421
KMUH-IRB-960012
No
Jung-Fa,Tsai, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Not Provided
Principal Investigator: Jung-Fa Tsai, M.D., Ph.D. Kaohsiung Medical University
Kaohsiung Medical University Chung-Ho Memorial Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP