Status:
ACTIVE_NOT_RECRUITING
Case-Control Study of the Glycotest™ HCC Panel Vs AFP for the Detection of Early-stage Hepatocellular Carcinoma
Lead Sponsor:
Glycotest, Inc.
Conditions:
Carcinoma, Hepatocellular
Cirrhosis, Liver
Eligibility:
All Genders
18+ years
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-fetopro...
Detailed Description
Study Rationale: This study is designed to compare the ability of the Glycotest HCC Panel with that of AFP to differentiate between patients with early-stage Hepatocellular Carcinoma (HCC) against a ...
Eligibility Criteria
Inclusion
- 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.
- Subject must be able to understand and provide informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
May 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
766 Patients enrolled
Trial Details
Trial ID
NCT03878550
Start Date
May 22 2019
End Date
December 31 2025
Last Update
March 13 2025
Active Locations (20)
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1
Cedars- Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of California Los Angeles
Los Angeles, California, United States, 90095
3
Kaiser Permanente Northern California
San Francisco, California, United States, 94115
4
University of California- San Francisco
San Francisco, California, United States, 94115