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

NCT03878550 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 766

Last updated 2025-03-13

No results posted yet for this study

Summary

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.

Conditions

  • Carcinoma, Hepatocellular
  • Cirrhosis, Liver

Sponsors & Collaborators

  • Glycotest, Inc.

    lead INDUSTRY

Principal Investigators

  • Josep Llovet, MD · Icahn School of Medicine at Mount Sinai

  • Jorge Marrero, MD · University of Pennsylvania Medical Center

  • Amit Singal, MD · UT Southwestern Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2023-08-25
Completion
2025-12-31

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878550 on ClinicalTrials.gov