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

N
Naga Chalasani, MD

Primary Investigator

Enrolling By Invitation
18 years and older
All
Phase N/A
3000 participants needed
1 Location

Overview

The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liverhepatocellular cancer (HCC) detection in a surveillance population.

Description

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

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Hepatocellular Carcinoma, Hepatocellular Cancer, Hepatitis B, Cirrhosis, Liver Cancer
  • Age: 18 Years
  • Gender: All

Inclusion Criteria:
  1. Be 18 years of age or older.
  2. Understand the study procedures, be able to provide written informed consent tohe study, and have authorization for release of data, includinghealth data and images, to the study Investigator, Sponsor, and regulatoryuthorities.
  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 portalhypertension (as evidenced by the presence of intra-abdominal varices, orzed umbilical vein, or ascites or splenomegaly or thrombocytopenia[defined as Platelet count < 150,000]). The imaging results must have beenbtained within 5 years of study enrollment.
      • Liver stiffness ≥4.71 kilopascal (kPa) by Magnetic Resonance (MR)graphy or ≥12.1 kPa by vibration controlled transient elastography.
      • Presence of varices on endoscopy or imaging and presence of a chronic liverdisease. 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 exceptkin cancer.
  2. Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.
  3. Child-Pugh class C liver function at the time of enrollment, except for those on thewaiting list for transplant.
  4. Solid liver nodule >1 cm by ultrasound or elevated Alpha-fetoprotein (AFP) (>100g/mL) in 12 months preceding the qualifying surveillance imaging visit withoutubsequent documentation of HCC negative or LIRADS 1 (Liver Imaging Reporting and Dataystem) 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 duringhe 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.
  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 afterdication.
    2. Estimated glomerular filtration rate <35 mL/min and not on hemodialysis.

Updated on 15 May 2024. Study ID: 2021-01
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