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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629421
• Other study ID #: KMUH-IRB-960012
• Status: Completed
• Phase: N/A
• First received: February 26, 2008
• Last updated: August 20, 2017
• Start date: January 1, 2001
• Est. completion date: December 31, 2016

Study information

• Verified date: August 2017
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Image diagnosis or biochemical diagnosis or presence of portal hypertension

Exclusion Criteria:

• Presence of hepatocellular carcinoma

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cirrhosis
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of hepatocellular carcinoma	nodule (with or without seum AFP greater than 400 ng/ml) confirmed by biopsy	during observation