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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,200
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.
Providence Facey Medical Foundation
Mission Hills, California, United States
RECRUITINGGuardian Angel Research Center
Tampa, Florida, United States
RECRUITINGGI Research Mercy Medical Center
Baltimore, Maryland, United States
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
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test for the detection of liver cancers within healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease.
Time frame: 1 - 9 months
Ascertain Reference Range(s)
Ascertain reference range determination(s) for select CpG methylation sites
Time frame: 1 - 9 months
Ascertain Sample Stability
Sample stability under various shipping conditions
Time frame: 1 - 9 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
South Texas Research Institute
Edinburg, Texas, United States
RECRUITINGTexas Gastro Research
El Paso, Texas, United States
RECRUITINGImpact Research Institute
Waco, Texas, United States
RECRUITINGDigestive & Liver Disease Specialist
Norfolk, Virginia, United States
RECRUITING