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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01846949

Acronym

ALDUS

Enrollment

1000

Registered

2013-05-06

Start date

2013-05-31

Completion date

2022-10-31

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

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 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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Hepatocellular carcinoma	Expected time frame; 2.5 years	Tumor marker measurement and ultrasonography are conducted at an interval of 13 weeks, until total events (HCC occurrence) reach to 120 cases.

Secondary

Measure	Time frame
Survival	2 and 5 year after patient enrollment

Countries

Japan

Outcome results