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

Recruiting

• Conditions: Hepatocellular Cancer; Hepatitis B; Hepatocellular Carcinoma; Liver Cancer; Cirrhosis
• Interventions: Device: Study CT/MRI Imaging; Diagnostic Test: Oncoguard™ Liver Test; Device: Standard of Care CT/MRI Imaging

• Registration Number: NCT05064553
• Lead Sponsor: Exact Sciences Corporation

Brief Summary

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

Detailed Description

The study will include participants aged 18 years and older who are at increased risk for HCC, including individuals with liver cirrhosis or non-cirrhotic individuals with chronic hepatitis B infection.

Study Timeline

• Study Start: 2021-07-26
• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-01
• Status Verified: 2023-12
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-01
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound Surveillance Group	Study CT/MRI Imaging	Subjects will undergo standard of care ultrasound surveillance imaging. Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up with CT or MRI as well as other procedures as needed. Subjects with negative ultrasound will be sent for a study CT/MRI.
CT/MRI Surveillance Group	Oncoguard™ Liver Test	Subjects will undergo standard of care CT/MRI surveillance imaging.
Ultrasound Surveillance Group	Standard of Care CT/MRI Imaging	Subjects will undergo standard of care ultrasound surveillance imaging. Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up with CT or MRI as well as other procedures as needed. Subjects with negative ultrasound will be sent for a study CT/MRI.
Ultrasound Surveillance Group	Oncoguard™ Liver Test	Subjects will undergo standard of care ultrasound surveillance imaging. Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up with CT or MRI as well as other procedures as needed. Subjects with negative ultrasound will be sent for a study CT/MRI.
CT/MRI Surveillance Group	Standard of Care CT/MRI Imaging	Subjects will undergo standard of care CT/MRI surveillance imaging.

Primary Outcome Measures

Name	Time	Method
To demonstrate that Oncoguard™ Liver early-stage HCC sensitivity is non-inferior to that of ultrasound within a 5% margin	A maximum of 30 days from study or standard-of-care CT or MRI exam.
To demonstrate that Oncoguard™ Liver HCC specificity exceeds 82%	A maximum of 30 days from study or standard-of-care CT or MRI exam.

Secondary Outcome Measures

Name	Time	Method
To determine a point estimate and 95% confidence interval for Oncoguard™ Liver overall HCC sensitivity	A maximum of 30 days from study or standard-of-care CT or MRI exam.

Trial Locations

Locations (72)

Arizona Digestive Health - Sun City; 🇺🇸 Sun City, Arizona, United States

University of Florida - College of Medicine; 🇺🇸 Jacksonville, Florida, United States

ENCORE Borland Groover Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Florida Research Institute; 🇺🇸 Lakewood, Florida, United States

Illinois Gastroenterology Group; 🇺🇸 Glenview, Illinois, United States

Texas Gastro Clinic; 🇺🇸 El Paso, Texas, United States

Gastroenterology and Internal Medicine Specialists; 🇺🇸 Lake Barrington, Illinois, United States

Patient First Clinical Trials; 🇺🇸 Nottingham, Maryland, United States

Kansas City VA Medical Center; 🇺🇸 Kansas City, Missouri, United States

Brooklyn VA Medical Center; 🇺🇸 Brooklyn, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University Gastroenterology West River; 🇺🇸 Providence, Rhode Island, United States

Lubbock Digestive Disease Associates; 🇺🇸 Lubbock, Texas, United States

Texas Digestive Disease Consultants - San Marcos; 🇺🇸 San Marcos, Texas, United States

Washington Gastroenterology - Bellevue; 🇺🇸 Bellevue, Washington, United States

Washington Gastroenterology - Tacoma; 🇺🇸 Tacoma, Washington, United States

Arizona Health Research; 🇺🇸 Chandler, Arizona, United States

Franco Felizarta, MD; 🇺🇸 Bakersfield, California, United States

Gastroenterology & Liver Institute; 🇺🇸 Escondido, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Providence Facey Medical Foundation; 🇺🇸 Mission Hills, California, United States

United Medical Doctors; 🇺🇸 Murrieta, California, United States

VA Palo Alto Healthcare System; 🇺🇸 Palo Alto, California, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

California Liver Research Institute; 🇺🇸 Pasadena, California, United States

Cadena Care Institute; 🇺🇸 Poway, California, United States

Inland Empire Clinical Trials; 🇺🇸 Rialto, California, United States

Research & Education, Inc; 🇺🇸 San Diego, California, United States

San Jose Gastroenterology; 🇺🇸 San Jose, California, United States

Rocky Mountain Gastroenterology; 🇺🇸 Littleton, Colorado, United States

Washington DC VA Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of Florida Hepatology Research at CTRB; 🇺🇸 Gainesville, Florida, United States

San Marcus Research Clinic; 🇺🇸 Miami Lakes, Florida, United States

Miami VA Healthcare System; 🇺🇸 Miami, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Digestive Health Services; 🇺🇸 Downers Grove, Illinois, United States

Avicenna Clinical Research; 🇺🇸 Oak Lawn, Illinois, United States

NAVREF - Indiana Institute for Medical Research (IIMC); 🇺🇸 Indianapolis, Indiana, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Indianapolis Gastroenterology Research Foundation; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Delta Research Partners; 🇺🇸 Monroe, Louisiana, United States

Louisiana Research Center, LLC; 🇺🇸 Shreveport, Louisiana, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Southern Therapy and Advanced Research LLC (STAR); 🇺🇸 Jackson, Mississippi, United States

St. Louis University; 🇺🇸 Saint Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Manhattan Clinical Research, LLC; 🇺🇸 New York, New York, United States

Digestive Health Partners; 🇺🇸 Asheville, North Carolina, United States

Duke University Health Systems; 🇺🇸 Durham, North Carolina, United States

VA North East Ohio Health Care System; 🇺🇸 Cleveland, Ohio, United States

Great Lakes Medical Research - Susquehanna Research Group; 🇺🇸 Camp Hill, Pennsylvania, United States

Corporal Michael J. Crescenz VA Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Xiaoli MA MD; 🇺🇸 Philadelphia, Pennsylvania, United States

Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Wilkes-Barre VA Medical Center; 🇺🇸 Wilkes-Barre, Pennsylvania, United States

Ralph H Johnson VAMC; 🇺🇸 Charleston, South Carolina, United States

Gastro One; 🇺🇸 Germantown, Tennessee, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Tranquil Clinical Research; 🇺🇸 Webster, Texas, United States

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States

UVA Gastroenterology; 🇺🇸 Charlottesville, Virginia, United States

Gastroenterology Associates, PC; 🇺🇸 Manassas, Virginia, United States

Digestive & Liver Disease Specialists; 🇺🇸 Norfolk, Virginia, United States

Richmond VA Medical Center; 🇺🇸 Richmond, Virginia, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Velocity Clinical Research; 🇺🇸 Spokane, Washington, United States

UW Digestive Health Center; 🇺🇸 Madison, Wisconsin, United States