Status:
UNKNOWN
Surveillance Study for HCC by Combining Biomarkers With Imaging (ALDUS)
Lead Sponsor:
ALDUS Study Group
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Brief Summary
This study is intended to be a prospective observational study at multiple sites, not a randomized controlled trial (RCT). The uses of the biomarkers has been approved by government regulations and ad...
Detailed Description
Data are being stored in the electric data capture (EDC) server.
Eligibility Criteria
Inclusion
- Patients with compensated cirrhosis. No discrimination by underlying causes will done.
- Patients aged 18 years and older
- Patients agree to the informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01846949
Start Date
May 1 2013
End Date
October 1 2022
Last Update
July 21 2021
Active Locations (1)
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1
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Tokyo, Japan, 113-8655