CClinicalTrials.gg
CompletedNCT00629421Updated Aug 22, 2017

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

An observational study in Cirrhosis and Hepatocellular Carcinoma, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,200
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Cirrhosis
  • Hepatocellular Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 1,200 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Well-dignosed patients with cirrhosis

Inclusion criteria

  • Image diagnosis or biochemical diagnosis or presence of portal hypertension

Exclusion criteria

Exclusion Criteria:

  • Presence of hepatocellular carcinoma
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,200 participants (actual)
06

What researchers measure

Primary outcomes

  1. development of hepatocellular carcinoma

    nodule (with or without seum AFP greater than 400 ng/ml) confirmed by biopsy

    Time frame: during observation

07

Study locations

1 site
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, 807, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00629421
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Jung-Fa,Tsai (Professor of Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital) — Principal investigator
First posted
Mar 6, 2008
Start date
Jan 1, 2001
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016
Last update
Aug 22, 2017

Study contacts

Jung-Fa Tsai, M.D., Ph.D.
principal investigator · Kaohsiung Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion