ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
NCT ID: NCT05064553
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2990 participants
OBSERVATIONAL
2021-07-26
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Ultrasound Surveillance Group
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.
Study CT/MRI Imaging
Subjects with negative ultrasound will be sent for a study CT/MRI.
Standard of Care CT/MRI Imaging
Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up as well as other procedures as needed.
Oncoguard™ Liver Test
Subjects will have a blood sample collected for the Oncoguard™ Liver Test.
CT/MRI Surveillance Group
Subjects will undergo standard of care CT/MRI surveillance imaging.
Standard of Care CT/MRI Imaging
Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up as well as other procedures as needed.
Oncoguard™ Liver Test
Subjects will have a blood sample collected for the Oncoguard™ Liver Test.
Interventions
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Study CT/MRI Imaging
Subjects with negative ultrasound will be sent for a study CT/MRI.
Standard of Care CT/MRI Imaging
Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up as well as other procedures as needed.
Oncoguard™ Liver Test
Subjects will have a blood sample collected for the Oncoguard™ Liver Test.
Eligibility Criteria
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Inclusion Criteria
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. Endoscopy or imaging results must have been obtained within 5 years of study enrollment.
OR
2. Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for \>6 months)
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Exact Sciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Binu John
Role: PRINCIPAL_INVESTIGATOR
Miami VA Healthcare System
Locations
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Arizona Health Research
Chandler, Arizona, United States
Arizona Digestive Health - Sun City
Sun City, 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 D.C., District of Columbia, United States
University of Florida Hepatology Research at CTRB
Gainesville, Florida, 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
Miami VA Healthcare System
Miami, Florida, United States
University of Miami
Miami, Florida, United States
San Marcus Research Clinic
Miami Lakes, Florida, United States
Tampa General Hospital
Tampa Bay, Florida, United States
Digestive Health Services
Downers Grove, Illinois, United States
Illinois Gastroenterology Group
Glenview, Illinois, United States
GI Alliance of Illinois - Gurnee
Gurnee, Illinois, United States
Gastroenterology and Internal Medicine Specialists
Lake Barrington, 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
Patient First Clinical Trials
Nottingham, Maryland, 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
Kansas City VA Medical Center
Kansas City, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Brooklyn VA Medical Center
Brooklyn, New York, 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
Cleveland Clinic Foundation
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
University Gastroenterology West River
Providence, Rhode Island, 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
Texas Gastro Clinic
El Paso, Texas, United States
Baylor - Saint Luke's Medical Center
Houston, Texas, United States
Lubbock Digestive Disease Associates
Lubbock, Texas, United States
Texas Digestive Disease Consultants - San Marcos
San Marcos, 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
Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States
Richmond VA Medical Center
Richmond, Virginia, United States
Washington Gastroenterology - Bellevue
Bellevue, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Velocity Clinical Research
Spokane, Washington, United States
Washington Gastroenterology - Tacoma
Tacoma, Washington, United States
UW Digestive Health Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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2021-01
Identifier Type: -
Identifier Source: org_study_id
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