NCT05064553

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,990 (actual)
• Sponsor: Exact Sciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study will include participants aged 18 years and older who are at increased risk for HCC, including individuals with liver cirrhosis or non-cirrhotic individuals with chronic hepatitis B infection.

Conditions

• Hepatocellular Carcinoma
• Hepatocellular Cancer
• Hepatitis B
• Cirrhosis
• Liver Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-26
• Primary completion: 2025-09-12
• Completion: 2026-12-01
• First posted: 2021-10-01
• Last updated: 2025-10-15

Locations

76 sites across 1 country: United States