Detection of Early-Stage Hepatocellular Carcinoma

What is the Purpose of this Study?

The goal of this study is to help develop an investigational diagnostic test (Glycotest HCC Panel) that will distinguish between cirrhosis of the liver and early-stage hepatocellular carcinoma (HCC), a specific type of cancer originating in the liver. Researchers will collect blood samples and clinical data from patients diagnosed with cirrhosis of the liver or early-stage HCC; the study will then evaluate the proposed new diagnostic test using these samples. Participants may also be asked questions about their general health, medical condition, and medications. The results obtained with the Glycotest HCC Panel will be compared to results from a currently used test called Alpha-Fetoprotein (AFP) for the discrimination of patients with cirrhosis from those with early-stage HCC. The study will determine whether the Glycotest HCC Panel provides useful information on a consistent basis.

Eligibility

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.

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.

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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center

More about this Clinical Trial

What is the full name of this clinical trial?

IIT2020-01-YANG-G1001:Case-Control Study of the Glycotest HCC Panel vs AFP for the Detection of Early-Stage Hepatocellular Carcinoma

Study Details

Disease Type/Condition

Gastrointestinal Cancer, Liver Cancer

Principal Investigator

Yang, Ju Dong

Co-Investigators

Alexander Kuo, Juvelyn Palomique, Mazen Noureddin, Nicholas Nissen, Vinay Sundaram, Walid Ayoub

Age Group

Adult

Phase

II (Cancer Control)

IRB Number

STUDY00000399

ClinicalTrials.gov ID

NCT03878550

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org