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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00629421
First Posted: March 6, 2008
Last Update Posted: August 22, 2017
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 (Responsible Party):
Jung-Fa,Tsai, Kaohsiung Medical University Chung-Ho Memorial Hospital
  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:


Further study details as provided by Jung-Fa,Tsai, Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • development of hepatocellular carcinoma [ Time Frame: during observation ]
    nodule (with or without seum AFP greater than 400 ng/ml) confirmed by biopsy


Enrollment: 1200
Actual Study Start Date: January 1, 2001
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 2016 (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. As anti-viral therapy was found to decrease risk for HCC, patients with those therapy will be excluded.
  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629421


Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
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

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
First Submitted: February 26, 2008
First Posted: March 6, 2008
Last Update Posted: August 22, 2017
Last Verified: August 2017

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