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NCT03878550 · ClinicalTrials.gov registry record
Case-Control Study of the Glycotest™ HCC Panel Vs AFP for the Detection of Early-stage Hepatocellular Carcinoma
A clinical trial of Cirrhosis, Liver and Carcinoma, Hepatocellular, sponsored by Glycotest.
- Active
- Registry status
- 766
- Enrollment target
- 20
- Study locations
NCT03878550: Active study of Cirrhosis, Liver and Carcinoma, Hepatocellular, sponsored by Glycotest.
NCT03878550 is a study of Cirrhosis, Liver and Carcinoma, Hepatocellular that is active but no longer recruiting, run by Glycotest. The registered enrollment target is 766 participants, above the 220-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (248% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03878550, a study of Cirrhosis, Liver and Carcinoma, Hepatocellular, is active but no longer recruiting, sponsored by Glycotest.
- ACTIVE NOT RECRUITING
- Registry status
- 766 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Area under the receiver operating characteristics curve
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 |
What the registry record for NCT03878550 still lists
NCT03878550 is an observational study that tracks outcomes without assigning an intervention. The registered 766 participants enrollment target is mid-sized for trials with a published cap, above the 220-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (248% higher).
The record links to 2 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 0 interventions.
NCT03878550 names 20 study sites across 10 states, led by California, New York, Texas.
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.
Who is sponsoring clinical trial NCT03878550?
This trial is sponsored by Glycotest, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03878550's enrollment target sits among peer trials
766 4th of 34 higher than 31 of 34 other Cirrhosis, Liver trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis, Liver trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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