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

Brief description of study

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

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
  • The subjects will have surveillance imaging by either ultrasound or CT/MRI (without recent abdominal ultrasound or AFP). Within 14 days of the surveillance imaging, approximately 40 mL of blood will be collected and sent to a central laboratory for testing with the Oncoguard Liver test.
  • Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up with CT and/or MRI as well as other procedures as needed. 
  • Subjects with negative ultrasound will be sent for a study CT/MRI within 30 days of blood collection.
  • Subjects that return for a second standard-of-care surveillance imaging visit will have an additional study blood collection. 
  • Within 14 days of the surveillance imaging, approximately 40 mL of blood will be collected and sent to a central laboratory for testing with the Oncoguard Liver test.
  • Clinical, lab, and imaging data, including the standard of care surveillance imaging visit, will be collected for each subject. 
  • Data will be collected until either 8 months after the first blood collection without a second surveillance visit or the results from a second surveillance visit are available.

Eligibility of study

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 01 Aug 2024. Study ID: 2021-01, GI-EXACT-ALTUS-2021-01, 13101
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