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Blood test aims to outshine ultrasound for liver cancer detection

NCT ID NCT03694600

Diagnosis Sponsor: Helio Genomics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This trial is testing a blood test that looks for DNA markers of liver cancer in people with liver cirrhosis, who are at high risk for developing the disease. The test is compared to standard ultrasound to see which method is better at detecting liver cancer. If the blood test proves accurate, it could offer a less invasive and more convenient screening option.

What this could mean

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

Active substance
Multi-analyte blood test
What this could lead to
If successful, this blood test could offer a simpler, more accurate way to screen for liver cancer in high-risk people with cirrhosis, potentially catching tumors earlier.
What could go wrong
The test is still being evaluated and may not prove more effective than standard ultrasound. False positives or negatives could occur, and results may not apply to all populations.

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

About 1,900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2019

Expected to finish

Dec 2027

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

The maximum study duration for any given subject participating in the trial will be approximately 21 months (includes Initial Surveillance Visit and Follow-Up Visits at 6 months, 12 months and 18 months). No study-related lab assessments, imaging or procedures shall be required for any subject after the Study Duration Period. Subject Eligibility Screening Period: 14 days Study Duration Period: Up to 21 months (includes Initial Surveillance Visit for all subjects and up to three Follow-Up Visits ONLY for subjects with indeterminant findings by diagnostic imaging) The maximum observational window for any subject enrolled in the study is expected to be approximately 21 months (for subjects with indeterminant findings by diagnostic imaging).

Ages

21 to 84 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Subject is age 21 to 84 (inclusive) * Subject is able to read, comprehend and sign the Informed Consent Document * Subject is willing and able to undergo liver cancer surveillance by ultrasound and the multi-analyte blood Test * Subject is able and willing to undergo diagnostic imaging by multiphasic MRI with contrast according to the Study Protocol * Subject has been diagnosed with liver cirrhosis by one or more of the following methods: 1. Clinical diagnosis by blood analytes (APRI ≥ 1.5 or Bonacini cirrhosis discriminant score ≥ 8 or Lok index \> 0.5) 2. Ultrasound and Elastography \> 12.5 kPa (Vibration-controlled transient elastography, Point shear wave elastography, Two-dimensional shear wave ultrasound and transient elastography or Magnetic Resonance Elastography) 3. Diagnostic imaging by CT or MRI (liver cirrhosis indicated on radiology report) 4. Liver biopsy (liver cirrhosis indicated on pathology report) Exclusion Criteria: * The study investigator deems the subject's participation to be unsafe due to an underlying medical condition * Subject has previously been diagnosed with a primary liver cancer or a non-liver cancer that has metastasized * Subject has previously submitted a blood sample to Helio Health (HELIO) through a separate clinical protocol * Subject is unable or unwilling to submit blood samples for testing, undergo ultrasound or undergo diagnostic imaging by multiphasic MRI with contrast as required for the Study Protocol * Subject has any internal metallic device or fragment, including but not limited to: A pacemaker, artificial joint or valve, surgical clips, pins, plates, screws, wire mesh or shrapnel * It is unsafe for the subject to receive an MRI contrast dye due to pregnancy or severe kidney disease * Subject would not routinely be recommended for HCC surveillance * Subject received an abdominal ultrasound or diagnostic imaging by MRI or CT to image the liver within the past 5 months

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver

As listed by the trial registrant

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

Liver cirrhosis

Contacts and locations

Locations

  • AZ Liver Health (Chandler)

    Chandler, Arizona, 85224, United States

  • AZ Liver Health (Glendale, Peoria)

    Peoria, Arizona, 85381, United States

  • AZ Liver Health (Tucson)

    Tucson, Arizona, 85712, United States

  • Alliance Research Centers

    Irvine, California, 92612, United States

  • Atlanta Gastroenterology

    Atlanta, Georgia, 30308, United States

  • Banner University Hospital (University of Arizona Tucson)

    Tucson, Arizona, 85724, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Covenant Metabolic LLC

    Fort Myers, Florida, 33012, United States

  • Covenant Metabolics LLC

    Sarasota, Florida, 34240, United States

  • Digestive & Liver Disease Specialists (DLDS) - Norfolk

    Norfolk, Virginia, 23502, United States

  • Gastro One in Memphis

    Memphis, Tennessee, 38104, United States

  • Gastroenterology Group of Naples

    Naples, Florida, 34102, United States

  • Harborview Medical Center (University of Washington)

    Seattle, Washington, 98104, United States

  • Impact Research Institute

    Waco, Texas, 76710, United States

  • Kansas City Research Institute (KCRI)

    Kansas City, Missouri, 64131, United States

  • Konkord Research

    Houston, Texas, 77065, United States

  • Liver Center of Texas

    Dallas, Texas, 75234, United States

  • Liver Institute Northwest

    Seattle, Washington, 98105, United States

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Methodist Dallas Medical Center

    Dallas, Texas, 79936, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103, United States

  • Piedmont Research Institute

    Atlanta, Georgia, 30309, United States

  • Quality Medical

    Nashville, Tennessee, 37211, United States

  • SouthTexas Research Institute

    Edinburg, Texas, 78539, United States

  • St Luke's Hospital of Kansas City

    Kansas City, Kansas, 64111, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Texas Gastro Clinic

    El Paso, Texas, 79936, United States

  • Texas Liver Institute - American Research Corp.

    San Antonio, Texas, 78215, United States

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112, United States

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45627, United States

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045, United States

  • University of Florida Clinical and Translational Science Institute

    Gainesville, Florida, 32610, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Miami - Schiff Center for Liver Diseases

    Miami, Florida, 33136, United States

  • University of South California

    Los Angeles, California, 90033, United States

  • VA Richmond

    Richmond, Virginia, 23249, United States

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