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

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

Observational Exact Sciences Corporation · NCT05064553

This study is testing a new blood test to see if it can help find liver cancer earlier in adults who are at high risk due to liver cirrhosis or chronic hepatitis B.

Quick facts

Study typeObservational
Enrollment2500 (estimated)
Ages18 Years and up
SexAll
SponsorExact Sciences Corporation Industry-sponsored
Drugs / interventionsChemotherapy, radiation
Locations72 sites (Chandler, Arizona and 71 other locations)
Trial IDNCT05064553 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with liver cirrhosis or chronic hepatitis B infection who are undergoing surveillance imaging.

Not a fit: Patients without liver disease or those not at increased risk for hepatocellular carcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate detection of liver cancer, improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using similar blood tests for cancer detection, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Chandler, Arizona and 71 other locations

+22 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatocellular CarcinomaHepatocellular CancerHepatitis BCirrhosisLiver CancerBlood Sample CollectionCT/MRIUltrasound
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.