ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
1 other identifier
observational
2,990
1 country
76
Brief Summary
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Longer than P75 for all trials
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2021
CompletedFirst Submitted
Initial submission to the registry
September 21, 2021
CompletedFirst Posted
Study publicly available on registry
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedOctober 15, 2025
June 1, 2025
4.1 years
September 21, 2021
October 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
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.
Study Arms (2)
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.
CT/MRI Surveillance Group
Subjects will undergo standard of care CT/MRI surveillance imaging.
Interventions
Subjects with negative ultrasound will be sent for a study CT/MRI.
Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up as well as other procedures as needed.
Subjects will have a blood sample collected for the Oncoguard™ Liver Test.
Eligibility Criteria
Subjects 18 years of age and older who are at an increased risk for HCC and for whom HCC surveillance is appropriate, including subjects with cirrhosis and non-cirrhotic subjects with Hepatitis B.
You may qualify if:
- Be 18 years of age or older.
- 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.
- Present for surveillance imaging due to increased risk for HCC, including either:
- 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.
- Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for \>6 months)
You may not qualify if:
- Known cancer diagnosis (including active malignancy) within the past 5 years except for nonmelanoma skin cancer.
- Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.
- Known Child-Pugh class C liver function at the time of enrollment, except for those on the waiting list for transplant.
- 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.
- Females known to be pregnant at the time of enrollment.
- Illness that the Investigator believes poses a significant risk of mortality during the study period, including but not limited to
- Congestive heart failure with ejection fraction \<50%
- Chronic lung disease requiring supplemental oxygen.
- History of recent stroke.
- 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.
- Not able to have IV contrast for CT or MRI due to
- Allergy to IV contrast and unwilling or unable to receive IV contrast after pre-medication.
- Estimated glomerular filtration rate \<35 mL/min and not on hemodialysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
Arizona Health Research
Chandler, Arizona, 85225, United States
Arizona Digestive Health - Sun City
Sun City, Arizona, 85251, United States
Franco Felizarta, MD
Bakersfield, California, 93301, United States
Gastroenterology & Liver Institute
Escondido, California, 92025, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Providence Facey Medical Foundation
Mission Hills, California, 91345, United States
United Medical Doctors
Murrieta, California, 92563, United States
VA Palo Alto Healthcare System
Palo Alto, California, 94303, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
California Liver Research Institute
Pasadena, California, 91107, United States
Cadena Care Institute
Poway, California, 92064, United States
Inland Empire Clinical Trials
Rialto, California, 92377, United States
Research & Education, Inc
San Diego, California, 92105, United States
San Jose Gastroenterology
San Jose, California, 95128, United States
Rocky Mountain Gastroenterology
Littleton, Colorado, 80120, United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422, United States
University of Florida Hepatology Research at CTRB
Gainesville, Florida, 32610, United States
University of Florida - College of Medicine
Jacksonville, Florida, 32209, United States
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, 32256, United States
Florida Research Institute
Lakewood, Florida, 34211, United States
Miami VA Healthcare System
Miami, Florida, 33125, United States
University of Miami
Miami, Florida, 33136, United States
San Marcus Research Clinic
Miami Lakes, Florida, 33014, United States
Tampa General Hospital
Tampa Bay, Florida, 33606, United States
Digestive Health Services
Downers Grove, Illinois, 60515, United States
Illinois Gastroenterology Group
Glenview, Illinois, 60026, United States
GI Alliance of Illinois - Gurnee
Gurnee, Illinois, 60031, United States
Gastroenterology and Internal Medicine Specialists
Lake Barrington, Illinois, 60010, United States
Avicenna Clinical Research
Oak Lawn, Illinois, 60463, United States
NAVREF - Indiana Institute for Medical Research (IIMC)
Indianapolis, Indiana, 46201, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Delta Research Partners
Monroe, Louisiana, 71201, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Patient First Clinical Trials
Nottingham, Maryland, 21236, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902, United States
Southern Therapy and Advanced Research LLC (STAR)
Jackson, Mississippi, 39216, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
St. Louis University
St Louis, Missouri, 63104, United States
Brooklyn VA Medical Center
Brooklyn, New York, 11209, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Manhattan Clinical Research, LLC
New York, New York, 10279, United States
Digestive Health Partners
Asheville, North Carolina, 28801, United States
Duke University Health Systems
Durham, North Carolina, 27710, United States
VA North East Ohio Health Care System
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Great Lakes Medical Research - Susquehanna Research Group
Camp Hill, Pennsylvania, 17011, United States
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Xiaoli MA MD
Philadelphia, Pennsylvania, 19107, United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Wilkes-Barre VA Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
University Gastroenterology West River
Providence, Rhode Island, 02904, United States
Ralph H Johnson VAMC
Charleston, South Carolina, 29401, United States
Gastro One
Germantown, Tennessee, 38138, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Gastro Clinic
El Paso, Texas, 79936, United States
Baylor - Saint Luke's Medical Center
Houston, Texas, 77030, United States
Lubbock Digestive Disease Associates
Lubbock, Texas, 79410, United States
Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, 78666, United States
Tranquil Clinical Research
Webster, Texas, 77598, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
UVA Gastroenterology
Charlottesville, Virginia, 22903, United States
Gastroenterology Associates, PC
Manassas, Virginia, 20110, United States
Digestive & Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226, United States
Richmond VA Medical Center
Richmond, Virginia, 23249, United States
Washington Gastroenterology - Bellevue
Bellevue, Washington, 98056, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Velocity Clinical Research
Spokane, Washington, 99202, United States
Washington Gastroenterology - Tacoma
Tacoma, Washington, 98405, United States
UW Digestive Health Center
Madison, Wisconsin, 53705, United States
Biospecimen
Blood samples will be labeled with unique codes containing letters and numbers. Blood specimens may not be used in their entirety. Residual samples and their derivatives may be archived indefinitely for further analysis and future research. Specimens that are not processed, or specimens de-accessioned from the biorepository, will be destroyed with a record of removal and destruction maintained for seven years.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Binu John
Miami VA Healthcare System
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2021
First Posted
October 1, 2021
Study Start
July 26, 2021
Primary Completion
September 12, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
October 15, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available from 2 years and ending 4 years after publication.
- Access Criteria
- Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/IEC approvals or waivers as applicable to conduct research.
Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include test, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and the clinical study report (when applicable) will also be shared