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

NCT03878550 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Glycotest, Inc.
Status	ACTIVE_NOT_RECRUITING
Enrolment	766
Start date	Wed May 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Dec 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Carcinoma, Hepatocellular
• Cirrhosis, Liver

Countries

United States, Israel