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

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

Detailed Description
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Subjects age 18 years and older who are at an increased risk for HCC and for whom HCC surveillance is appropriate, including subjects with cirrhosis or non-cirrhotic subjects with Hepatitis B. Approximately 3,000 subjects are expected to be enrolled, comprised of approximately 2,222 ultrasound surveillance subjects and 778 subjects under surveillance with CT/MRI.

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

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

Intervention / Treatment
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* Device: Study CT/MRI Imaging
* Device: Standard of Care CT/MRI Imaging
* Diagnostic Test: Oncoguard™ Liver Test


Participation Criteria
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Eligibility Criteria
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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: 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. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ultrasound Surveillance Group<br>Subjects will undergo standard of care ultrasound surveillance imaging. Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up with CT or MRI as well as other procedures as needed. Subjects with negative ultrasound will be sent for a study CT/MRI. | Device: Study CT/MRI Imaging<br>* Subjects with negative ultrasound will be sent for a study CT/MRI.<br>Device: Standard of Care CT/MRI Imaging<br>* Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up as well as other procedures as needed.<br>Diagnostic Test: Oncoguard™ Liver Test<br>* Subjects will have a blood sample collected for the Oncoguard™ Liver Test.<br>|
| CT/MRI Surveillance Group<br>Subjects will undergo standard of care CT/MRI surveillance imaging. | Diagnostic Test: Oncoguard™ Liver Test<br>* Subjects will have a blood sample collected for the Oncoguard™ Liver Test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Oncoguard™ Liver in a HCC surveillance population |  | A maximum of 30 days from study or standard-of-care CT or MRI exam. | 
| Specificity of Oncoguard™ Liver in a HCC surveillance population |  | A maximum of 30 days from study or standard-of-care CT or MRI exam. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Oncoguard™ Liver among confirmed HCC subjects |  | A maximum of 30 days from study or standard-of-care CT or MRI exam. | 
| Specificity of Oncoguard™ Liver among confirmed non-HCC subjects |  | A maximum of 30 days from study or standard-of-care CT or MRI exam. | 
| Early-stage sensitivity of Oncoguard™ Liver in a HCC surveillance population |  | A maximum of 30 days from study or standard-of-care CT or MRI exam. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Sample Collection, CT/MRI, Ultrasound, Combined Hepatocellular and Cholangiocarcinoma, HCC Surveillance