ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study summary
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
Eligibility
Primary outcome measure(s)
- 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.
Trial sites (76)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Health Research | Chandler | Arizona | |
| Arizona Digestive Health - Sun City | Sun City | Arizona | |
| Franco Felizarta, MD | Bakersfield | California | |
| Gastroenterology & Liver Institute | Escondido | California | |
| Cedars Sinai Medical Center | Los Angeles | California | |
| Providence Facey Medical Foundation | Mission Hills | California | |
| United Medical Doctors | Murrieta | California | |
| VA Palo Alto Healthcare System | Palo Alto | California | |
| Stanford University Medical Center | Palo Alto | California | |
| California Liver Research Institute | Pasadena | California | |
| Cadena Care Institute | Poway | California | |
| Inland Empire Clinical Trials | Rialto | California | |
| Research & Education, Inc | San Diego | California | |
| San Jose Gastroenterology | San Jose | California | |
| Rocky Mountain Gastroenterology | Littleton | Colorado | |
| Washington DC VA Medical Center | Washington D.C. | District of Columbia | |
| University of Florida Hepatology Research at CTRB | Gainesville | Florida | |
| University of Florida - College of Medicine | Jacksonville | Florida | |
| ENCORE Borland Groover Clinical Research | Jacksonville | Florida | |
| Florida Research Institute | Lakewood | Florida | |
| Miami VA Healthcare System | Miami | Florida | |
| University of Miami | Miami | Florida | |
| San Marcus Research Clinic | Miami Lakes | Florida | |
| Tampa General Hospital | Tampa Bay | Florida | |
| Digestive Health Services | Downers Grove | Illinois | |
| Illinois Gastroenterology Group | Glenview | Illinois | |
| GI Alliance of Illinois - Gurnee | Gurnee | Illinois | |
| Gastroenterology and Internal Medicine Specialists | Lake Barrington | Illinois | |
| Avicenna Clinical Research | Oak Lawn | Illinois | |
| NAVREF - Indiana Institute for Medical Research (IIMC) | Indianapolis | Indiana | |
| Indiana University | Indianapolis | Indiana | |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | |
| Delta Research Partners | Monroe | Louisiana | |
| Louisiana Research Center, LLC | Shreveport | Louisiana | |
| Patient First Clinical Trials | Nottingham | Maryland | |
| University of Michigan | Ann Arbor | Michigan | |
| Henry Ford Health System | Detroit | Michigan | |
| Mayo Clinic Rochester | Rochester | Minnesota | |
| Southern Therapy and Advanced Research LLC (STAR) | Jackson | Mississippi |
+ 36 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05064553 on ClinicalTrials.gov ↗ ← All trials in the USA