Latest1 information on COVID-19
©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT03878550
Case-Control Study of the Glycotest™ HCC Panel vs AFP for the Detection of Early-stage Hepatocellular Carcinoma
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
Inclusion Criteria:
Cases
1. Males and females ages 18 years or older.
2. 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.
3. 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.
4. 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.
5. Child-Pugh score A-B8.
6. Subject must be able to understand and provide informed consent.
Controls
1. Males and females ages 18 or older.
2. 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.
3. 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:
1. Negative multiphase CT scan or MRI with contrast at screening/baseline visit, OR
2. Negative abdominal US at both screening/baseline visit AND 6-month follow-up
visit, OR
3. Negative abdominal US at screening/baseline visit AND negative multiphase CT scan
or MRI with contrast at 6-month or earlier follow-up visit.
4. Child-Pugh score A-B8.
5. Subject must be able to understand and provide informed consent.
Exclusion Criteria:
Cases
1. Uncontrolled ascites.
2. Uncontrolled encephalopathy.
3. History of liver transplant.
4. 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.
5. Prior treatment of tumor.
6. Any significant non-liver-related medical condition in which expected survival is less
than 1 year.
Controls
1. 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.
2. Uncontrolled ascites.
3. History of liver transplantation.
4. Uncontrolled encephalopathy.
5. 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.
6. Any significant non-liver-related medical condition in which expected survival is less
than 1 year.
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Akiko Mizuta
650-498-5691