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

NCT ID: NCT00629421

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2001-01-01
• Study Completion Date: 2016-12-31

Brief Summary

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

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.

Conditions

Cirrhosis; Hepatocellular Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Image diagnosis or biochemical diagnosis or presence of portal hypertension

Exclusion Criteria

• Presence of hepatocellular carcinoma

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jung-Fa,Tsai

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jung-Fa Tsai, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KMUH-IRB-960012

Identifier Type: -

Identifier Source: org_study_id