- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629421
Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study
August 20, 2017 updated by: Jung-Fa,Tsai, Kaohsiung Medical University Chung-Ho Memorial Hospital
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
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
1200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Well-dignosed patients with cirrhosis
Description
Inclusion Criteria:
- Image diagnosis or biochemical diagnosis or presence of portal hypertension
Exclusion Criteria:
- Presence of hepatocellular carcinoma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
development of hepatocellular carcinoma
Time Frame: during observation
|
nodule (with or without seum AFP greater than 400 ng/ml) confirmed by biopsy
|
during observation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jung-Fa Tsai, M.D., Ph.D., Kaohsiung Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2001
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
February 26, 2008
First Submitted That Met QC Criteria
March 5, 2008
First Posted (Estimate)
March 6, 2008
Study Record Updates
Last Update Posted (Actual)
August 22, 2017
Last Update Submitted That Met QC Criteria
August 20, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUH-IRB-960012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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