Study for Clinical Significance of Use of AFP, AFP-L3 and DCP Versus US Alone in Surveillance for HCC
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Liver Cirrhosis
Both
Liver Cirrhosis
Trial Information
Study for Clinical Significance of Use of AFP, AFP-L3 and DCP Versus US Alone in Surveillance for HCC
Inclusion Criteria:
- Patients with compensated cirrhosis. No discrimination by underlying causes will
done.
- Patients aged 18 years and older
- Patients agree to the informed consent
Exclusion Criteria:
- Patients with liver cancer at the time of enrollment
- Patients who have experienced HCC or other malignant tumor with in five (5) years
- Women with pregnancies
- Patients who are likely to be transplanted within one (1) year
- Patients with ≥ 3 mg/dL of total bilirubin
- Patients with uncontrollable ascites
- Patients with ≥ Grade II of hepatic encephalopathy
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Hepatocellular carcinoma
Outcome Description:
Tumor marker measurement and ultrasonography are conducted at an interval of 13 weeks, until total events (HCC occurrence) reach to 120 cases.
Outcome Time Frame:
Expected time frame; 2.5 years
Safety Issue:
No
Authority:
Japan: Institutional Review Board
Study ID:
ALDUS
NCT ID:
NCT01846949
Start Date:
May 2013
Completion Date:
October 2020
Related Keywords:
- Liver Cirrhosis
- Liver Cirrhosis
- Fibrosis
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