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New blood panel aims to catch liver cancer before it spreads

NCT ID NCT03878550

Diagnosis Sponsor: Glycotest, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing a blood test panel called Glycotest HCC to see if it detects early-stage liver cancer better than the standard alpha-fetoprotein (AFP) test. The study includes 766 people with cirrhosis, some of whom have early liver cancer and some who do not. Participants give blood samples, and researchers compare how well each test identifies cancer. The goal is to find a more sensitive surveillance tool for people at high risk.

What this could mean

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

Active substance
a blood test panel called Glycotest HCC
What this could lead to
If it works, this blood test could help doctors find liver cancer at an earlier, more treatable stage in people with cirrhosis.
What could go wrong
This is a validation study, not a proven test. The panel may not perform well enough in real-world settings, and a blood test alone cannot replace imaging or other clinical checks.

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 766 people

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

Started

May 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 study population will comprise male and female adult patients with early-stage HCC against a background of cirrhosis (cases) as well as at-risk cirrhotic patients (controls). Enrollment of the aggregate of HCC cases with single lesions ≥ 3 cm and with multiple lesions will be capped at 50% of total cases. Enrollment of Chronic Hepatitis C cases and controls with sustained virologic response (SVR) to therapy will be matched. Cases and controls will be matched based on age, sex and etiology.

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: Cases 1. Males and females ages 18 years or older. 2. Treatment-naïve HCC as defined by LI-RADS (Liver Imaging Reporting and Data System) LR-5 or OPTN (Organ Procurement and Transplantation Network) 5 CT or MRI criteria (all lesions must exhibit arterial phase hyper-enhancement), or histologic evidence. 3. Early-stage HCC defined by single lesion ≤ 5 cm or ≤ 3 lesions ≤ 3 cm determined at enrollment or within 100 days prior without vascular invasion. 4. Cirrhosis based on serum biomarkers (FibroSure®/FibroTest \> 0.74, APRI (AST to Platelet Ratio Index) \> 2, or FIB-4 (Fibrosis-4) \> 3.25), histology, imaging, elastography, or clinical evidence of portal hypertension in the setting of known chronic liver disease. 5. Child-Pugh score A-B8. 6. Subject must be able to understand and provide informed consent. Controls 1. Males and females ages 18 or older. 2. Cirrhosis based on serum biomarkers (FibroSure®/FibroTest \> 0.74, APRI \> 2, or FIB-4 \> 3.25), histology, imaging, elastography, or clinical evidence of portal hypertension in the setting of known chronic liver disease. 3. Evidence of the absence of a solid hepatic mass, suspicious for HCC, at enrollment or within 100 days prior based on one of the following: 1. Negative multiphase CT scan or MRI with contrast at screening/baseline visit, OR 2. Negative abdominal US at both screening/baseline visit AND 6-month follow-up visit, OR 3. Negative abdominal US at screening/baseline visit AND negative multiphase CT scan or MRI with contrast at 6-month or earlier follow-up visit. 4. Child-Pugh score A-B8. 5. Subject must be able to understand and provide informed consent. Exclusion Criteria: Cases 1. Uncontrolled ascites. 2. Uncontrolled encephalopathy. 3. History of liver transplant. 4. Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment, including mixed HCC-CCA (cholangiocarcinoma). If previously diagnosed with malignancy, subject must be in remission for at least 5 years prior to enrollment. Prior history of HCC, including resection of HCC at any time, is excluded. 5. Prior treatment of tumor. 6. Any significant non-liver-related medical condition in which expected survival is less than 1 year. Controls 1. Imaging evidence of solid hepatic mass, suspicious for HCC, including lesions meeting LI-RADS LR-3 or LR-4, OPTN-3 or OPTN-4, or LI-RADS LR-M criteria. 2. Uncontrolled ascites. 3. History of liver transplantation. 4. Uncontrolled encephalopathy. 5. Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment (if previously diagnosed with malignancy, subject must be in remission for at least 5 years prior to enrollment). History of HCC including resection of HCC at any time, is excluded. 6. Any significant non-liver-related medical condition in which expected survival is less than 1 year.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver hepatocellular carcinoma

As listed by the trial registrant

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

Carcinoma, hepatocellular Cirrhosis, liver

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75201, United States

  • Cedars- Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Hebrew University- Hadassah Medical Center

    Jerusalem, 91120, Israel

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital of the University of Pennsylvania (HUP)

    Philadelphia, Pennsylvania, 19104, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Kaiser Permanente Northern California

    San Francisco, California, 94115, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Miami VA Healthcare System

    Miami, Florida, 33125, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Stanford University School of Medicine

    Stanford, California, 94304, United States

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of California- San Francisco

    San Francisco, California, 94115, United States

  • University of Florida

    Gainesville, Florida, 32608, United States

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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