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Hepatocellular CarcinomaNCT05064553

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

An observational study of Hepatocellular Carcinoma and Hepatocellular Cancer, run by Exact Sciences Corporation at 76 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Study CT/MRI Imaging and Oncoguard™ Liver Test
Type of treatment
Medical device
How many people
2,990 participants
Where
76 sitesUnited States
Study dates
26 Jul 2021to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.
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  • 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
  • Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis B surface antigen present for >6 months)

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

76 sites in 1 country.

76 sites in 1 country

United States76 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Digestive Health Partners

    Asheville, North Carolina, 28801

  • Franco Felizarta, MD

    Bakersfield, California, 93301

  • Washington Gastroenterology - Bellevue

    Bellevue, Washington, 98056

  • Brooklyn VA Medical Center

    Brooklyn, New York, 11209

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Great Lakes Medical Research - Susquehanna Research Group

    Camp Hill, Pennsylvania, 17011

  • Arizona Health Research

    Chandler, Arizona, 85225

  • Ralph H Johnson VAMC

    Charleston, South Carolina, 29401

  • UVA Gastroenterology

    Charlottesville, Virginia, 22903

  • VA North East Ohio Health Care System

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Digestive Health Services

    Downers Grove, Illinois, 60515

  • Duke University Health Systems

    Durham, North Carolina, 27710

  • Texas Gastro Clinic

    El Paso, Texas, 79936

  • Gastroenterology & Liver Institute

    Escondido, California, 92025

  • University of Florida Hepatology Research at CTRB

    Gainesville, Florida, 32610

  • Gastro One

    Germantown, Tennessee, 38138

  • Illinois Gastroenterology Group

    Glenview, Illinois, 60026

  • GI Alliance of Illinois - Gurnee

    Gurnee, Illinois, 60031

  • Baylor - Saint Luke's Medical Center

    Houston, Texas, 77030

  • NAVREF - Indiana Institute for Medical Research (IIMC)

    Indianapolis, Indiana, 46201

  • Indiana University

    Indianapolis, Indiana, 46202

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Southern Therapy and Advanced Research LLC (STAR)

    Jackson, Mississippi, 39216

  • University of Florida - College of Medicine

    Jacksonville, Florida, 32209

  • ENCORE Borland Groover Clinical Research

    Jacksonville, Florida, 32256

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

  • Gastroenterology and Internal Medicine Specialists

    Lake Barrington, Illinois, 60010

  • Florida Research Institute

    Lakewood, Florida, 34211

  • Rocky Mountain Gastroenterology

    Littleton, Colorado, 80120

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Lubbock Digestive Disease Associates

    Lubbock, Texas, 79410

  • UW Digestive Health Center

    Madison, Wisconsin, 53705

  • Gastroenterology Associates, PC

    Manassas, Virginia, 20110

  • Miami VA Healthcare System

    Miami, Florida, 33125

  • University of Miami

    Miami, Florida, 33136

  • San Marcus Research Clinic

    Miami Lakes, Florida, 33014

  • Providence Facey Medical Foundation

    Mission Hills, California, 91345

  • Delta Research Partners

    Monroe, Louisiana, 71201

  • United Medical Doctors

    Murrieta, California, 92563

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Manhattan Clinical Research, LLC

    New York, New York, 10279

  • Digestive & Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Patient First Clinical Trials

    Nottingham, Maryland, 21236

  • Avicenna Clinical Research

    Oak Lawn, Illinois, 60463

  • VA Palo Alto Healthcare System

    Palo Alto, California, 94303

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • California Liver Research Institute

    Pasadena, California, 91107

  • Corporal Michael J. Crescenz VA Medical Center

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Xiaoli MA MD

    Philadelphia, Pennsylvania, 19107

  • Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Cadena Care Institute

    Poway, California, 92064

  • University Gastroenterology West River

    Providence, Rhode Island, 02904

  • Inland Empire Clinical Trials

    Rialto, California, 92377

  • Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226

  • Richmond VA Medical Center

    Richmond, Virginia, 23249

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902

  • Research & Education, Inc

    San Diego, California, 92105

  • San Jose Gastroenterology

    San Jose, California, 95128

  • Texas Digestive Disease Consultants - San Marcos

    San Marcos, Texas, 78666

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Velocity Clinical Research

    Spokane, Washington, 99202

  • St. Louis University

    St Louis, Missouri, 63104

  • Arizona Digestive Health - Sun City

    Sun City, Arizona, 85251

  • Washington Gastroenterology - Tacoma

    Tacoma, Washington, 98405

  • Tampa General Hospital

    Tampa Bay, Florida, 33606

  • Washington DC VA Medical Center

    Washington D.C., District of Columbia, 20422

  • Tranquil Clinical Research

    Webster, Texas, 77598

  • Wilkes-Barre VA Medical Center

    Wilkes-Barre, Pennsylvania, 18711

Other trials in United States

About this study

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

Read the 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.

Being tested
Study CT/MRI Imaging, Standard of Care CT/MRI Imaging, Oncoguard™ Liver Test
Keywords
Blood Sample Collection, CT/MRI, Ultrasound, Combined Hepatocellular and Cholangiocarcinoma, HCC Surveillance
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms, Hepatitis B, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Study CT/MRI ImagingDevice

    Subjects with negative ultrasound will be sent for a study CT/MRI.

  • Standard of Care CT/MRI ImagingDevice

    Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up as well as other procedures as needed.

  • Oncoguard™ Liver TestDiagnostic test

    Subjects will have a blood sample collected for the Oncoguard™ Liver Test.

Study groups in NCT05064553
Study groupRoleWhat they receive
Ultrasound Surveillance GroupSubjects 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.
Receives: Device: Study CT/MRI Imaging; Device: Standard of Care CT/MRI Imaging; Diagnostic Test: Oncoguard™ Liver Test
CT/MRI Surveillance GroupSubjects will undergo standard of care CT/MRI surveillance imaging.
Receives: Device: Standard of Care CT/MRI Imaging; Diagnostic Test: Oncoguard™ Liver Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To demonstrate that Oncoguard™ Liver early-stage HCC sensitivity is non-inferior to that of ultrasound within a 5% margin

    Measured: A maximum of 30 days from study or standard-of-care CT or MRI exam.

  2. To demonstrate that Oncoguard™ Liver HCC specificity exceeds 82%

    Measured: A maximum of 30 days from study or standard-of-care CT or MRI exam.

Secondary outcomes (1)

  1. To determine a point estimate and 95% confidence interval for Oncoguard™ Liver overall HCC sensitivity

    Measured: A maximum of 30 days from study or standard-of-care CT or MRI exam.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2021
  2. Study start26 Jul 2021
  3. Primary completion12 Sep 2025
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
2,990 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05064553
Sponsor's protocol ID
2021-01
Status last verified
Jun 2025
First submitted
21 Sep 2021
Last updated
15 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • John BV, Camardo M, Singal AG, Parikh ND, Yang JD, Roberts LR, Silva AC, Chalasani N, Salgia R, Kisiel JB, Porter K, Elias PZ, Kielar-Grevstad E, Bruinsma JJ, Olson MC, Garces J, Limburg PJ. Multi-target blood test for hepatocellular carcinoma early detection: a cross-sectional analysis of the prospective ALTUS study. J Hepatol. 2026 Sep 26:S0168-8278(26)02904-1. doi: 10.1016/j.jhep.2026.09.011. Online ahead of print.

    PubMed 42800682

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma and Hepatocellular Cancer, run by Exact Sciences Corporation at 76 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To demonstrate that Oncoguard™ Liver early-stage HCC sensitivity is non-inferior to that of ultrasound within a 5% margin (time frame: A maximum of 30 days from study or standard-of-care CT or MRI exam.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05064553, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.

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