Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma
Helio Genomics
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
Inclusion Criteria: * Age 18 years or older. * Males and Females. * Having cirrhosis or meeting the AASLD guidelines for HCC * surveillance. * Clinically diagnosed with HCC or negative for HCC following disease * surveillance. * HCC positive Group: Subject has a recent (within 6 months of enrollment) clinically diagnosed, untreated hepatocellular carcinoma as defined by at least one ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC. * HCC negative Gr…
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.
Locations (7)
- Providence Facey Medical FoundationMission Hills, California
- Guardian Angel Research CenterTampa, Florida
- GI Research Mercy Medical CenterBaltimore, Maryland
- South Texas Research InstituteEdinburg, Texas
- Texas Gastro ResearchEl Paso, Texas
- Impact Research InstituteWaco, Texas