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

Sponsor
ALDUS Study Group (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT01846949
Collaborator
(none)
1,000
Enrollment
1
Location
113
Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    May 1, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Survival [2 and 5 year after patient enrollment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Graduate School of Medicine and Faculty of Medicine, The University of Tokyo Tokyo Japan 113-8655

    Sponsors and Collaborators

    • ALDUS Study Group

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ALDUS Study Group
    ClinicalTrials.gov Identifier:
    NCT01846949
    Other Study ID Numbers:
    • ALDUS
    First Posted:
    May 6, 2013
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jul 1, 2021
    Additional relevant MeSH terms:
    Liver Cirrhosis

    Study Results

    No Results Posted as of Jul 21, 2021