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

NCT01846949 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2021-07-21

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • ALDUS Study Group

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2021-12-31
Completion
2022-10-31

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01846949 on ClinicalTrials.gov