Surveillance Study for HCC by Combining Biomarkers With Imaging (ALDUS)
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
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedJuly 21, 2021
July 1, 2021
8.6 years
April 23, 2013
July 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Survival
2 and 5 year after patient enrollment
Eligibility Criteria
Patients with compensated cirrhosis.
You may qualify if:
- Patients with compensated cirrhosis. No discrimination by underlying causes will done.
- Patients aged 18 years and older
- Patients agree to the informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Tokyo, 113-8655, Japan
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2013
First Posted
May 6, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2021
Study Completion
October 1, 2022
Last Updated
July 21, 2021
Record last verified: 2021-07