ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
The primary objective is to assess overall sensitivity and specificity of Oncoguardâ„¢ 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.
Inclusion Criteria:
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:
OR
Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for >6 months)
Exclusion Criteria:
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
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
Tampa Bay, Florida 33606, United States
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