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

Running, not enrolling

Conditions studied: Hepatocellular Carcinoma, Hepatocellular Cancer, Hepatitis B, Cirrhosis, Liver Cancer

In brief

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

Key facts

Study ID

NCT05064553

Run by

Exact Sciences Corporation

People needed

2990

Starts

2021-07-26

Expected to finish

2026-12-01

Last updated by the study team

2025-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be 18 years of age or older.
• 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.
• Present for surveillance imaging due to increased risk for HCC, including either:
• 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
• Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for >6 months)

You may not qualify if…

• Known cancer diagnosis (including active malignancy) within the past 5 years except for nonmelanoma skin cancer.
• Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.
• Known Child-Pugh class C liver function at the time of enrollment, except for those on the waiting list for transplant.
• 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.
• Females known to be pregnant at the time of enrollment.
• Illness that the Investigator believes poses a significant risk of mortality during the study period, including but not limited to
• Congestive heart failure with ejection fraction <50%
• Chronic lung disease requiring supplemental oxygen.
• History of recent stroke.
• 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.
• Not able to have IV contrast for CT or MRI due to
• Allergy to IV contrast and unwilling or unable to receive IV contrast after pre-medication.
• Estimated glomerular filtration rate <35 mL/min and not on hemodialysis.

Where it is running

• 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
• Cadena Care Institute — Poway, California, United States
• Inland Empire Clinical Trials — Rialto, California, United States
• Research & Education, Inc — San Diego, California, United States
• San Jose Gastroenterology — San Jose, California, United States
• Rocky Mountain Gastroenterology — Littleton, Colorado, United States
• Washington DC VA Medical Center — Washington D.C., District of Columbia, United States
• University of Florida Hepatology Research at CTRB — Gainesville, Florida, United States
• University of Florida - College of Medicine — Jacksonville, Florida, United States
• ENCORE Borland Groover Clinical Research — Jacksonville, Florida, United States
• Florida Research Institute — Lakewood, Florida, United States
• Miami VA Healthcare System — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• San Marcus Research Clinic — Miami Lakes, Florida, United States
• Tampa General Hospital — Tampa Bay, Florida, United States
• Digestive Health Services — Downers Grove, Illinois, United States
• Arizona Health Research — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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