The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
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.
Study Type
OBSERVATIONAL
Enrollment
2,990
Subjects with negative ultrasound will be sent for a study CT/MRI.
Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up as well as other procedures as needed.
Subjects will have a blood sample collected for the Oncoguard™ Liver Test.
To demonstrate that Oncoguard™ Liver early-stage HCC sensitivity is non-inferior to that of ultrasound within a 5% margin
Time frame: A maximum of 30 days from study or standard-of-care CT or MRI exam.
To demonstrate that Oncoguard™ Liver HCC specificity exceeds 82%
Time frame: A maximum of 30 days from study or standard-of-care CT or MRI exam.
To determine a point estimate and 95% confidence interval for Oncoguard™ Liver overall HCC sensitivity
Time frame: A maximum of 30 days from study or standard-of-care CT or MRI exam.
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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
...and 66 more locations