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ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

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

NCT05064553•Exact Sciences Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be 18 years of age or older.
•2. Understand the study procedures, be able to provide written informed consent to participate in the study, and have authorization for release of data, including personal health data and images, to the study Investigator, Sponsor, and regulatory authorities.
•3. Present for surveillance imaging due to increased risk for HCC, including either:
•1. Diagnosis of cirrhosis based on at least one of the following:
•* Histology from a liver biopsy.
•* Ultrasound, CT, or MRI showing a cirrhotic liver combined with portal hypertension (as evidenced by the presence of intra-abdominal varices, or recanalized umbilical vein, or ascites or splenomegaly or thrombocytopenia \[defined as Platelet count \< 150,000\]). The imaging results must have been obtained within 5 years of study enrollment.
•* Liver stiffness ≥4.71 kilopascal (kPa) by Magnetic Resonance (MR) elastography or ≥12.1 kPa by vibration controlled transient elastography.
•* Presence of varices on endoscopy or imaging and presence of a chronic liver disease. Endoscopy or imaging results must have been obtained within 5 years of study enrollment.
•OR
•2. Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for \>6 months)

Exclusion Criteria

•1. Known cancer diagnosis (including active malignancy) within the past 5 years except for nonmelanoma skin cancer.
•2. Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.
•3. Known Child-Pugh class C liver function at the time of enrollment, except for those on the waiting list for transplant.
•4. Solid liver nodule \>1 cm by ultrasound or elevated Alpha-fetoprotein (AFP) (\>100 ng/mL) in 12 months preceding the qualifying surveillance imaging visit without subsequent documentation of HCC negative or LIRADS 1 (Liver Imaging Reporting and Data System) by diagnostic CT/MRI.
•5. Females known to be pregnant at the time of enrollment.
•6. Illness that the Investigator believes poses a significant risk of mortality during the study period, including but not limited to
•1. Congestive heart failure with ejection fraction \<50%
•2. Chronic lung disease requiring supplemental oxygen.
•3. History of recent stroke.
•7. Sustained virologic response (SVR) for Hepatitis C Virus (HCV) (undetectable HCV RNA 12 to 24 weeks after completion of antiviral therapy) for \>10 years prior to enrollment.
+3 more criteria

Locations (76)

Arizona Health Research

Chandler, Arizona, United States

Arizona Digestive Health - Sun City

Sun City, Arizona, United States

Franco Felizarta, MD

Bakersfield, California, United States

Gastroenterology & Liver Institute

Escondido, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Providence Facey Medical Foundation

Mission Hills, California, United States

United Medical Doctors

Murrieta, California, United States

VA Palo Alto Healthcare System

Palo Alto, California, United States

Stanford University Medical Center

Palo Alto, California, United States

California Liver Research Institute

Pasadena, California, United States

Key Dates

Start Date

July 26, 2021

Primary Completion Date

September 12, 2025

Completion Date

December 1, 2026

Last Updated

October 15, 2025

Enrollment

2,990

ACTUAL participants

Conditions

Hepatocellular CarcinomaHepatocellular CancerHepatitis BCirrhosisLiver Cancer

Interventions

Study CT/MRI Imaging

DEVICE

Standard of Care CT/MRI Imaging

DEVICE

Oncoguard™ Liver Test

DIAGNOSTIC_TEST

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Hepatocellular CarcinomaLiver Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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