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ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk

NCT05064553 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2990

Last updated 2025-10-15

No results posted yet for this study

Summary

The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.

Conditions

Interventions

DEVICE

Study CT/MRI Imaging

Subjects with negative ultrasound will be sent for a study CT/MRI.

DEVICE

Standard of Care CT/MRI Imaging

Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up as well as other procedures as needed.

DIAGNOSTIC_TEST

Oncoguard™ Liver Test

Subjects will have a blood sample collected for the Oncoguard™ Liver Test.

Sponsors & Collaborators

  • Exact Sciences Corporation

    lead INDUSTRY

Principal Investigators

  • Binu John · Miami VA Healthcare System

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-26
Primary Completion
2025-09-12
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT05064553 on ClinicalTrials.gov