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

Launched by EXACT SCIENCES CORPORATION · Sep 30, 2021

Keywords

ClinConnect Summary

The ALTUS clinical trial is studying a new test called Oncoguard™ Liver, which aims to detect hepatocellular carcinoma (HCC), a type of liver cancer, in people who are at higher risk. This trial is specifically looking at how well this test can identify cancer in individuals who have conditions like cirrhosis (scarring of the liver) or chronic Hepatitis B infection. If you are 18 years or older and are receiving regular imaging tests because of your increased risk for liver cancer, you might be eligible to participate.

Participants in this trial will undergo the Oncoguard™ Liver test along with routine surveillance imaging to help determine how effective the test is in finding liver cancer early. It’s important to note that individuals with certain recent cancer diagnoses, severe liver function issues, or those who have had specific treatments in the past few years may not qualify for this study. If you decide to participate, you will need to provide consent and may have your health information shared with researchers to help improve future liver cancer detection methods.

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Eligibility criteria

• 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. 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.