NCT05199259

Multi-analyte Blood Test Clinical Trial

Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Helio Genomics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Liver Cirrhosis
• Liver Cancer
• HCC
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Multi-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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-01-01
• Completion: 2025-03-01
• First posted: 2022-01-20
• Last updated: 2024-06-14

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study