Case-Control Study of the Glycotest™ HCC Panel Vs AFP for the Detection of Early-stage Hepatocellular Carcinoma

Running, not enrolling

Conditions studied: Carcinoma, Hepatocellular, Cirrhosis, Liver

In brief

Clinical guidelines (AASLD) recommend the use of abdominal ultrasound (US) for surveillance testing for the early detection of Hepatocellular Carcinoma (HCC). The serum protein biomarker alpha-fetoprotein (AFP) is commonly used to augment US but its use alone is not recommended by clinical guidelines. Despite evidence that HCC surveillance improves early detection and reduces mortality from HCC, current HCC surveillance tests lack sensitivity, leaving a significant proportion of patients to present with late-stage disease. The Glycotest HCC Panel has shown better sensitivity than AFP, which is ineffective for the detection of early-stage HCC. This clinical study seeks to validate the Glycotest HCC Panel using a large multicenter cohort of cases and controls that includes patients diagnosed with early-stage HCC against a background of cirrhosis and cirrhotic patients without HCC (at risk) undergoing an established surveillance protocol.

Key facts

Study ID

NCT03878550

Run by

Glycotest, Inc.

People needed

766

Starts

2019-05-22

Expected to finish

2025-12-31

Last updated by the study team

2025-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cases
• Males and females ages 18 years or older.
• 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.
• 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.
• 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.
• Child-Pugh score A-B8.
• Subject must be able to understand and provide informed consent.
• Controls
• Males and females ages 18 or older.
• 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.
• 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:
• Negative multiphase CT scan or MRI with contrast at screening/baseline visit, OR
• Negative abdominal US at both screening/baseline visit AND 6-month follow-up visit, OR
• Negative abdominal US at screening/baseline visit AND negative multiphase CT scan or MRI with contrast at 6-month or earlier follow-up visit.
• Child-Pugh score A-B8.
• Subject must be able to understand and provide informed consent.

You may not qualify if…

• Cases
• Uncontrolled ascites.
• Uncontrolled encephalopathy.
• History of liver transplant.
• 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.
• Prior treatment of tumor.
• Any significant non-liver-related medical condition in which expected survival is less than 1 year.
• Controls
• 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.
• Uncontrolled ascites.
• History of liver transplantation.
• Uncontrolled encephalopathy.
• 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.
• Any significant non-liver-related medical condition in which expected survival is less than 1 year.

Where it is running

• Cedars- Sinai Medical Center — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Kaiser Permanente Northern California — San Francisco, California, United States
• University of California- San Francisco — San Francisco, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• University of Florida — Gainesville, Florida, United States
• Miami VA Healthcare System — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Maryland, Baltimore — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• NYU Langone Health — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Hospital of the University of Pennsylvania (HUP) — Philadelphia, Pennsylvania, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Hebrew University- Hadassah Medical Center — Jerusalem, Israel

Full record on ClinicalTrials.gov

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