RecruitingNCT05199259

Multi-analyte Blood Test Clinical Trial

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

Sponsor

Helio Genomics

Enrollment

1,200 participants

Start Date

Mar 1, 2022

Study Type

OBSERVATIONAL

Conditions

Liver Cancer Hepatocellular Carcinoma Liver Cirrhosis HCC

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new multi-marker blood test to detect liver cancer (hepatocellular carcinoma, or HCC) in people with chronic liver disease or cirrhosis — with the goal of catching it earlier and more accurately than current methods. **You may be eligible if...** - You are 18 or older - You have cirrhosis or are enrolled in a liver cancer surveillance program - You have either been recently diagnosed with liver cancer (HCC) OR have been confirmed cancer-free through recent imaging **You may NOT be eligible if...** - You have already received treatment for your liver cancer - You do not have a diagnosis of chronic liver disease or cirrhosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.