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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 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.

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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.

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

FieldValue
Enrollment Target 766 participants
Start Date 2019-05-22
Est. Completion 2025-12-31

Sponsor

Glycotest

1 total trials

What the Registry Record Tells You About NCT03878550

The ClinicalTrials.gov registry entry for NCT03878550 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 766 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 220-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (248% higher). The listed sponsor is Glycotest, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 0 interventions.

NCT03878550 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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