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

Liver Cirrhosis Clinical Trial

— ALDUS  

Official title:

Study for Clinical Significance of Use of Alphafetoprotein (AFP), AFP-L3 and Des-gamma-carboxy Prothrombin (DCP) Versus US Alone in Surveillance for HCC

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01846949
• Other study ID #: ALDUS
• Status: Enrolling by invitation
• Start date: May 2013
• Est. completion date: October 2022

Study information

• Verified date: July 2021
• Source: ALDUS Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: October 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cirrhosis

Locations

Country	Name	City	State
Japan	Graduate School of Medicine and Faculty of Medicine, The University of Tokyo	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
ALDUS Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatocellular carcinoma	Tumor marker measurement and ultrasonography are conducted at an interval of 13 weeks, until total events (HCC occurrence) reach to 120 cases.	Expected time frame; 2.5 years
Secondary	Survival		2 and 5 year after patient enrollment