New blood test aims to catch liver cancer earlier in At-Risk patients

NCT ID NCT05064553

Diagnosis Sponsor: Exact Sciences Corporation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new blood test called Oncoguard Liver to see how well it detects liver cancer (hepatocellular carcinoma) in people at increased risk, such as those with cirrhosis or hepatitis B. About 3,000 participants will provide a blood sample and undergo imaging like ultrasound or CT/MRI. The goal is to see if the blood test is as good as or better than standard ultrasound for early detection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Oncoguard™ Liver blood test
What this could lead to: If successful, this blood test could offer a more accurate and convenient way to detect liver cancer early in high-risk individuals, potentially replacing or supplementing ultrasound.
What could go wrong: This is a diagnostic accuracy study, not a treatment trial. The test may not prove superior to ultrasound, and false positives or negatives could still occur. Results are preliminary until fully analyzed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,990 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Be 18 years of age or older. 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: 1. Known cancer diagnosis (including active malignancy) within the past 5 years except for nonmelanoma skin cancer. 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.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver Fibrosis hepatitis B virus infection hepatocellular carcinoma liver cancer Liver Neoplasms pediatric hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhosis Hepatitis B Hepatocellular cancer Hepatocellular carcinoma Liver cancer

Contacts and locations

Locations

Arizona Digestive Health - Sun City

Sun City, Arizona, 85251, United States
Arizona Health Research

Chandler, Arizona, 85225, United States
Avicenna Clinical Research

Oak Lawn, Illinois, 60463, United States
Baylor - Saint Luke's Medical Center

Houston, Texas, 77030, United States
Bon Secours Liver Institute of Richmond

Richmond, Virginia, 23226, United States
Brooklyn VA Medical Center

Brooklyn, New York, 11209, United States
Cadena Care Institute

Poway, California, 92064, United States
California Liver Research Institute

Pasadena, California, 91107, United States
Cedars Sinai Medical Center

Los Angeles, California, 90048, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Corporal Michael J. Crescenz VA Medical Center

Philadelphia, Pennsylvania, 19104, United States
Delta Research Partners

Monroe, Louisiana, 71201, United States
Digestive & Liver Disease Specialists

Norfolk, Virginia, 23502, United States
Digestive Health Partners

Asheville, North Carolina, 28801, United States
Digestive Health Services

Downers Grove, Illinois, 60515, United States
Duke University Health Systems

Durham, North Carolina, 27710, United States
ENCORE Borland Groover Clinical Research

Jacksonville, Florida, 32256, United States
Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States
Florida Research Institute

Lakewood, Florida, 34211, United States
Franco Felizarta, MD

Bakersfield, California, 93301, United States
GI Alliance of Illinois - Gurnee

Gurnee, Illinois, 60031, United States
Gastro One

Germantown, Tennessee, 38138, United States
Gastroenterology & Liver Institute

Escondido, California, 92025, United States
Gastroenterology Associates, PC

Manassas, Virginia, 20110, United States
Gastroenterology and Internal Medicine Specialists

Lake Barrington, Illinois, 60010, United States
Great Lakes Medical Research - Susquehanna Research Group

Camp Hill, Pennsylvania, 17011, United States
Henry Ford Health System

Detroit, Michigan, 48202, United States
Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States
Illinois Gastroenterology Group

Glenview, Illinois, 60026, United States
Indiana University

Indianapolis, Indiana, 46202, United States
Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, 46237, United States
Inland Empire Clinical Trials

Rialto, California, 92377, United States
Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States
Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States
Lubbock Digestive Disease Associates

Lubbock, Texas, 79410, United States
Manhattan Clinical Research, LLC

New York, New York, 10279, United States
Mayo Clinic Rochester

Rochester, Minnesota, 55902, United States
Miami VA Healthcare System

Miami, Florida, 33125, United States
NAVREF - Indiana Institute for Medical Research (IIMC)

Indianapolis, Indiana, 46201, United States
Patient First Clinical Trials

Nottingham, Maryland, 21236, United States
Providence Facey Medical Foundation

Mission Hills, California, 91345, United States
Ralph H Johnson VAMC

Charleston, South Carolina, 29401, United States
Research & Education, Inc

San Diego, California, 92105, United States
Richmond VA Medical Center

Richmond, Virginia, 23249, United States
Rocky Mountain Gastroenterology

Littleton, Colorado, 80120, United States
San Jose Gastroenterology

San Jose, California, 95128, United States
San Marcus Research Clinic

Miami Lakes, Florida, 33014, United States
Southern Therapy and Advanced Research LLC (STAR)

Jackson, Mississippi, 39216, United States
St. Louis University

St Louis, Missouri, 63104, United States
Stanford University Medical Center

Palo Alto, California, 94304, United States
Tampa General Hospital

Tampa Bay, Florida, 33606, United States
Texas Digestive Disease Consultants - San Marcos

San Marcos, Texas, 78666, United States
Texas Gastro Clinic

El Paso, Texas, 79936, United States
Tranquil Clinical Research

Webster, Texas, 77598, United States
UT Southwestern Medical Center

Dallas, Texas, 75390, United States
UVA Gastroenterology

Charlottesville, Virginia, 22903, United States
UW Digestive Health Center

Madison, Wisconsin, 53705, United States
United Medical Doctors

Murrieta, California, 92563, United States
University Gastroenterology West River

Providence, Rhode Island, 02904, United States
University of Florida - College of Medicine

Jacksonville, Florida, 32209, United States
University of Florida Hepatology Research at CTRB

Gainesville, Florida, 32610, United States
University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States
University of Miami

Miami, Florida, 33136, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States
University of Vermont Medical Center

Burlington, Vermont, 05401, United States
VA North East Ohio Health Care System

Cleveland, Ohio, 44106, United States
VA Palo Alto Healthcare System

Palo Alto, California, 94303, United States
Velocity Clinical Research

Spokane, Washington, 99202, United States
Virginia Mason Medical Center

Seattle, Washington, 98101, United States
Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States
Washington Gastroenterology - Bellevue

Bellevue, Washington, 98056, United States
Washington Gastroenterology - Tacoma

Tacoma, Washington, 98405, United States
Wilkes-Barre VA Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States
Xiaoli MA MD

Philadelphia, Pennsylvania, 19107, United States

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