Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma
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.
Arms & interventions
- Diagnostic TestMulti-analyte Blood Test
A clinical diagnostic test based upon the detection and quantification of DNA methylation markers in cell-free DNA (cfDNA) isolated from plasma and of tumor-specific proteins isolated from serum.
Outcome measures
Primary
Independent performance measure of sensitivity and specificity of a multi-analyte blood test
The primary objective is to measure the performance (sensitivity and specificity) the multi-analyte blood Test for the detection of liver cancers in high-risk particiapnats.
Time frame: 1 - 9 months
Secondary
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test
Time frame: 1 - 9 months
Ascertain Reference Range(s)
Time frame: 1 - 9 months
Ascertain Sample Stability
Time frame: 1 - 9 months
Eligibility criteria
Study locations (7)
Providence Facey Medical Foundation
Mission Hills, California, 91345
Guardian Angel Research Center
Tampa, Florida, 33614
GI Research Mercy Medical Center
Baltimore, Maryland, 21202
South Texas Research Institute
Edinburg, Texas, 78539
Texas Gastro Research
El Paso, Texas, 79936
Impact Research Institute
Waco, Texas, 76710
Digestive & Liver Disease Specialist
Norfolk, Virginia, 23502