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

NCT03878550 | Active Not Recruiting

• 1 other identifier: G-1001
• Study Type: observational
• Target: 766
• Locations: 2 countries
• Sites: 20

Brief 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

Outcome Measures

Primary Outcomes (1)

• AUROC

  Area under the receiver operating characteristics curve

  At enrollment

Secondary Outcomes (1)

• Sensitivity

  At enrollment

Study Arms (2)

Cases

Male and female adult patients with early-stage hepatocellular carcinoma against a background of liver cirrhosis.

Controls

Male and female adult patients with liver cirrhosis at risk for hepatocellular carcinoma.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise male and female adult patients with early-stage HCC against a background of cirrhosis (cases) as well as at-risk cirrhotic patients (controls). Enrollment of the aggregate of HCC cases with single lesions ≥ 3 cm and with multiple lesions will be capped at 50% of total cases. Enrollment of Chronic Hepatitis C cases and controls with sustained virologic response (SVR) to therapy will be matched. Cases and controls will be matched based on age, sex and etiology.

You may qualify if:

• Cases
• Males and females ages 18 years or older.
• Treatment-naïve HCC as defined by LI-RADS (Liver Imaging Reporting and Data System) LR-5 or OPTN (Organ Procurement and Transplantation Network) 5 CT or MRI criteria (all lesions must exhibit arterial phase hyper-enhancement), or histologic evidence.
• Early-stage HCC defined by single lesion ≤ 5 cm or ≤ 3 lesions ≤ 3 cm determined at enrollment or within 100 days prior without vascular invasion.
• Cirrhosis based on serum biomarkers (FibroSure®/FibroTest \> 0.74, APRI (AST to Platelet Ratio Index) \> 2, or FIB-4 (Fibrosis-4) \> 3.25), histology, imaging, elastography, or clinical evidence of portal hypertension in the setting of known chronic liver disease.
• Child-Pugh score A-B8.
• Subject must be able to understand and provide informed consent.
• Controls
• Males and females ages 18 or older.
• Cirrhosis based on serum biomarkers (FibroSure®/FibroTest \> 0.74, APRI \> 2, or FIB-4 \> 3.25), histology, imaging, elastography, or clinical evidence of portal hypertension in the setting of known chronic liver disease.
• Evidence of the absence of a solid hepatic mass, suspicious for HCC, at enrollment or within 100 days prior based on one of the following:
• Negative multiphase CT scan or MRI with contrast at screening/baseline visit, OR
• Negative abdominal US at both screening/baseline visit AND 6-month follow-up visit, OR
• Negative abdominal US at screening/baseline visit AND negative multiphase CT scan or MRI with contrast at 6-month or earlier follow-up visit.
• Child-Pugh score A-B8.

You may not qualify if:

• Cases
• Uncontrolled ascites.
• Uncontrolled encephalopathy.
• History of liver transplant.
• Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment, including mixed HCC-CCA (cholangiocarcinoma). If previously diagnosed with malignancy, subject must be in remission for at least 5 years prior to enrollment. Prior history of HCC, including resection of HCC at any time, is excluded.
• Prior treatment of tumor.
• Any significant non-liver-related medical condition in which expected survival is less than 1 year.
• Controls
• Imaging evidence of solid hepatic mass, suspicious for HCC, including lesions meeting LI-RADS LR-3 or LR-4, OPTN-3 or OPTN-4, or LI-RADS LR-M criteria.
• Uncontrolled ascites.
• History of liver transplantation.
• Uncontrolled encephalopathy.
• Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment (if previously diagnosed with malignancy, subject must be in remission for at least 5 years prior to enrollment). History of HCC including resection of HCC at any time, is excluded.
• Any significant non-liver-related medical condition in which expected survival is less than 1 year.

Sponsors & Collaborators

• Glycotest, Inc.: lead

Study Sites (20)

Cedars- Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Kaiser Permanente Northern California

San Francisco, California, 94115, United States

Location

University of California- San Francisco

San Francisco, California, 94115, United States

Location

Stanford University School of Medicine

Stanford, California, 94304, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Miami VA Healthcare System

Miami, Florida, 33125, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Hospital of the University of Pennsylvania (HUP)

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75201, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Hebrew University- Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Related Publications (1)

• Wang M, Sanda M, Comunale MA, Herrera H, Swindell C, Kono Y, Singal AG, Marrero J, Block T, Goldman R, Mehta A. Changes in the Glycosylation of Kininogen and the Development of a Kininogen-Based Algorithm for the Early Detection of HCC. Cancer Epidemiol Biomarkers Prev. 2017 May;26(5):795-803. doi: 10.1158/1055-9965.EPI-16-0974. Epub 2017 Feb 21.

  PMID: 28223431 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josep Llovet, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Jorge Marrero, MD

  University of Pennsylvania Medical Center

  PRINCIPAL INVESTIGATOR

• Amit Singal, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 18, 2019
• Study Start: May 22, 2019
• Primary Completion: August 25, 2023
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); IL (1)