Multi-analyte Blood Test Clinical Trial
Start Date
3/1/2022
Completion Date
12/1/2028
Summary
The objective of this study is the acquisition of whole blood samples and serum samples from participants with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing Hepatocellular Carcinoma (HCC) surveillance. These samples will be used for research purposes to develop and validate the Helio multi-analyte blood test.
Detailed Description
This study pertains to the collection of whole blood and serum specimens from participants undergoing Hepatocellular Carcinoma (HCC) surveillance. The participants will fall into two main groups, subjects diagnosed with HCC (HCC positive Group) or subjects without HCC (HCC negative Group). The HCC negative Group will be further divided into two sub-groups based on whether the absence of HCC has been determined using CT or MRI procedures (Sub-group 1) or ultrasound (Sub-group 2). Only the participants in sub-group 2 will receive a confirmatory ultrasound approximately 6 months (between 5 to 9 months) after enrollment to confirm the absence of HCC (6-month visit). This additional imaging study is necessary due to the low sensitivity of abdominal ultrasound to detect HCC lesions. Participants will be screened for eligibility to participate in the study based on their medical history and records. Participants with a recent confirmed Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the detection of Hepatocellular Carcinoma diagnosis of HCC (within 6 months of enrollment) may be enrolled in such way to ensure the cases are representative of the major liver disease etiologies in the surveillance population in the United States. Specifically, the following causes of cirrhosis will be selected: * Alcoholic steatohepatitis (ASH); * Hepatitis B virus (HBV); * Hepatitis C virus (HCV); * Non-alcoholic fatty liver disease (NAFLD); * Other genetic conditions that cause cirrhosis (i.e., hemochromatosis) These blood samples will be used to perform various studies to determine the utility of selected DNA methylation and protein markers for the liver cancer diagnostic test.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Multi-analyte Blood Test
Conditions
Locations
Gastroenterology and Liver Institute
Escondido, California 02025
United States
Providence Facey Medical Foundation
Mission Hills, California 91345
United States
UF Hepatology Research at CTRB
Gainesville, Florida 32610
United States
Guardian Angel Research Center
Tampa, Florida 33614
United States
South Texas Research Institute
Edinburg, Texas 78539
United States
Texas Gastro Research
El Paso, Texas 79936
United States
Impact Research Institute
Waco, Texas 76710
United States