Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
NCT05064553 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
Conditions Studied
Interventions
- DEVICE Study CT/MRI Imaging
- DEVICE Standard of Care CT/MRI Imaging
- DIAGNOSTIC_TEST Oncoguard™ Liver Test
Study Locations (20)
California
- Franco Felizarta, MD — Bakersfield
- Gastroenterology & Liver Institute — Escondido
- Cedars Sinai Medical Center — Los Angeles
- Providence Facey Medical Foundation — Mission Hills
- United Medical Doctors — Murrieta
- VA Palo Alto Healthcare System — Palo Alto
- Stanford University Medical Center — Palo Alto
- California Liver Research Institute — Pasadena
- Cadena Care Institute — Poway
- Inland Empire Clinical Trials — Rialto
- Research & Education, Inc — San Diego
- San Jose Gastroenterology — San Jose
Florida
- University of Florida Hepatology Research at CTRB — Gainesville
- University of Florida - College of Medicine — Jacksonville
- ENCORE Borland Groover Clinical Research — Jacksonville
- Florida Research Institute — Lakewood
Arizona
- Arizona Health Research — Chandler
- Arizona Digestive Health - Sun City — Sun City
Colorado
- Rocky Mountain Gastroenterology — Littleton
District of Columbia
- Washington DC VA Medical Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,990 participants |
| Start Date | 2021-07-26 |
| Est. Completion | 2026-12 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05064553
The ClinicalTrials.gov registry entry for NCT05064553 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,990 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exact Sciences Corporation, which has 42 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Study CT/MRI Imaging is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05064553 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05064553 about?
NCT05064553 is a clinical study titled "ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk". The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
What is the current status of trial NCT05064553?
This trial is currently active not recruiting. The enrollment target is 2,990 participants. The study started on 2021-07-26. Estimated completion is 2026-12.
What conditions does trial NCT05064553 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Liver Cancer, Cirrhosis, Hepatitis B, Hepatocellular Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05064553?
The interventions under investigation include: Study CT/MRI Imaging (DEVICE), Standard of Care CT/MRI Imaging (DEVICE), Oncoguard™ Liver Test (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05064553?
This trial is sponsored by Exact Sciences Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05064553 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.