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Active, not recruiting Observational

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

NCT05064553 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2021-07-26
Last updated
2025-10-15

Condition(s) studied

Hepatocellular CarcinomaHepatocellular CancerHepatitis BCirrhosisLiver Cancer

Investigational drug(s) / intervention(s)

Study CT/MRI ImagingStandard of Care CT/MRI ImagingOncoguard™ Liver Test

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

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.

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. 8. Not able to have IV contrast for CT or MRI due to 1. Allergy to IV contrast and unwilling or unable to receive IV contrast after pre-medication. 2. Estimated glomerular filtration rate \<35 mL/min and not on hemodialysis.

Primary outcome measure(s)

  • To demonstrate that Oncoguard™ Liver early-stage HCC sensitivity is non-inferior to that of ultrasound within a 5% margin — A maximum of 30 days from study or standard-of-care CT or MRI exam.
  • To demonstrate that Oncoguard™ Liver HCC specificity exceeds 82% — A maximum of 30 days from study or standard-of-care CT or MRI exam.

Trial sites (76)

FacilityCityRegionStatus
Arizona Health Research Chandler Arizona
Arizona Digestive Health - Sun City Sun City Arizona
Franco Felizarta, MD Bakersfield California
Gastroenterology & Liver Institute Escondido California
Cedars Sinai Medical Center Los Angeles California
Providence Facey Medical Foundation Mission Hills California
United Medical Doctors Murrieta California
VA Palo Alto Healthcare System Palo Alto California
Stanford University Medical Center Palo Alto California
California Liver Research Institute Pasadena California
Cadena Care Institute Poway California
Inland Empire Clinical Trials Rialto California
Research & Education, Inc San Diego California
San Jose Gastroenterology San Jose California
Rocky Mountain Gastroenterology Littleton Colorado
Washington DC VA Medical Center Washington D.C. District of Columbia
University of Florida Hepatology Research at CTRB Gainesville Florida
University of Florida - College of Medicine Jacksonville Florida
ENCORE Borland Groover Clinical Research Jacksonville Florida
Florida Research Institute Lakewood Florida
Miami VA Healthcare System Miami Florida
University of Miami Miami Florida
San Marcus Research Clinic Miami Lakes Florida
Tampa General Hospital Tampa Bay Florida
Digestive Health Services Downers Grove Illinois
Illinois Gastroenterology Group Glenview Illinois
GI Alliance of Illinois - Gurnee Gurnee Illinois
Gastroenterology and Internal Medicine Specialists Lake Barrington Illinois
Avicenna Clinical Research Oak Lawn Illinois
NAVREF - Indiana Institute for Medical Research (IIMC) Indianapolis Indiana
Indiana University Indianapolis Indiana
Indianapolis Gastroenterology Research Foundation Indianapolis Indiana
University of Iowa Hospitals and Clinics Iowa City Iowa
Delta Research Partners Monroe Louisiana
Louisiana Research Center, LLC Shreveport Louisiana
Patient First Clinical Trials Nottingham Maryland
University of Michigan Ann Arbor Michigan
Henry Ford Health System Detroit Michigan
Mayo Clinic Rochester Rochester Minnesota
Southern Therapy and Advanced Research LLC (STAR) Jackson Mississippi

+ 36 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05064553 on ClinicalTrials.gov ↗ ← All trials in the USA