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Case-Control Study of the Glycotest™ HCC Panel Vs AFP for the Detection of Early-stage Hepatocellular Carcinoma
NCT03878550 · View on ClinicalTrials.gov ↗
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 Studied
Study Locations (20)
California
- Cedars- Sinai Medical Center — Los Angeles
- University of California Los Angeles — Los Angeles
- Kaiser Permanente Northern California — San Francisco
- University of California- San Francisco — San Francisco
- Stanford University School of Medicine — Stanford
New York
- NYU Langone Health — New York
- Icahn School of Medicine at Mount Sinai — New York
- Montefiore Medical Center — The Bronx
Texas
- Baylor Scott & White Research Institute — Dallas
- The University of Texas Southwestern Medical Center — Dallas
- Baylor College of Medicine — Houston
Florida
- University of Florida — Gainesville
- Miami VA Healthcare System — Miami
Michigan
- University of Michigan — Ann Arbor
- Henry Ford Health System — Detroit
Illinois
- Northwestern University — Chicago
Maryland
- University of Maryland, Baltimore — Baltimore
Minnesota
- Mayo Clinic — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 766 participants |
| Start Date | 2019-05-22 |
| Est. Completion | 2025-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03878550
The ClinicalTrials.gov registry entry for NCT03878550 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 766 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glycotest, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03878550 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03878550 about?
NCT03878550 is a clinical study titled "Case-Control Study of the Glycotest™ HCC Panel Vs AFP for the Detection of Early-stage Hepatocellular Carcinoma". 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 guideline...
What is the current status of trial NCT03878550?
This trial is currently active not recruiting. The enrollment target is 766 participants. The study started on 2019-05-22. Estimated completion is 2025-12-31.
What conditions does trial NCT03878550 study?
This clinical trial studies the following conditions: Cirrhosis, Liver, Carcinoma, Hepatocellular. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT03878550?
This trial is sponsored by Glycotest, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03878550 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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