Testing a new method for detecting liver cancer in high-risk patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the sensitivity and specificity of the Oncoguard™ Liver test for detecting hepatocellular carcinoma (HCC) in individuals at increased risk. Participants will include adults aged 18 and older with liver cirrhosis or chronic hepatitis B infection. The study will involve blood sample collection and imaging techniques such as CT and MRI to monitor liver health. The goal is to improve early detection of liver cancer in a surveillance population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Arizona Digestive Health - Sun City
  Sun City, Arizona, United States Recruiting
• Franco Felizarta, MD
  Bakersfield, California, United States Recruiting
• Gastroenterology & Liver Institute
  Escondido, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Providence Facey Medical Foundation
  Mission Hills, California, United States Recruiting
• VA Palo Alto Healthcare System
  Palo Alto, California, United States Recruiting

+22 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Binu John — Miami VA Healthcare System
• Study coordinator: Haley Bowser
• Email: hbowser@exactsciences.com
• Phone: 608-381-8118

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using contrast-enhanced ultrasound to check Y-90 radioembolization response in liver cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.