Cirrhosis, Hepatitis B, Hepatocellular Cancer, Hepatocellular Carcinoma, Liver Cancer
Conditions
Keywords
Blood Sample Collection, CT/MRI, Ultrasound, Combined Hepatocellular and Cholangiocarcinoma, HCC Surveillance
Brief summary
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
Detailed description
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.
Interventions
DEVICEStandard 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.
DEVICEStudy CT/MRI Imaging
Subjects with negative ultrasound will be sent for a study CT/MRI.
DIAGNOSTIC_TESTOncoguard™ Liver Test
Subjects will have a blood sample collected for the Oncoguard™ Liver Test.
Sponsors
Exact Sciences Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| To determine a point estimate and 95% confidence interval for Oncoguard™ Liver overall HCC sensitivity | A maximum of 30 days from study or standard-of-care CT or MRI exam. |
Countries
United States
Outcome results
None listed