Surveillance Study for HCC by Combining Biomarkers With Imaging (ALDUS)

ALDUS Study Group

Status: Unknown

Conditions: Liver Cirrhosis

Study type: Observational

Funder types: Other

Identifiers

NCT01846949

ALDUS

Details and patient eligibility

About

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 adopted for surveillance programs in some countries, thus an RCT which compares patients followed by US alone with patients followed by both US and the biomarkers would raise an ethical conflict, especially in countries where the biomarkers have been routinely used.

For this study, enrolled patients will be followed by US and the biomarkers at regular intervals and classified after completing the study to evaluate the clinical effectiveness of the biomarkers. The comparisons of sensitivity, specificity, and other parameters with respect to tumor characteristics will be made among US alone, the biomarkers, and combined use of US and the biomarkers. Also economical effectiveness of using the biomarkers will be investigated in this study.

Requirement status is monitored every month.

Full description

Data are being stored in the electric data capture (EDC) server.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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