Study to Collect Blood Samples for Testing DNA Methylation and Protein Markers to Detect Hepatocellular Carcinoma in Adults with Liver Cirrhosis or at Risk of Liver Cancer

What this Trial Is About

Researchers are collecting whole blood and serum samples from adults diagnosed with untreated Hepatocellular Carcinoma HCC and from individuals undergoing surveillance for HCC without the disease. The purpose is to use these samples to develop and validate the Helio multi-analyte blood test, which aims to detect liver cancer by analyzing DNA methylation and protein markers. Participants include those with cirrhosis or at risk of HCC, representing major liver disease causes such as alcoholic steatohepatitis, hepatitis B or C, non-alcoholic fatty liver disease, and genetic conditions like hemochromatosis. Participants fall into three groups those recently diagnosed with untreated HCC confirmed by CT scan, MRI, or biopsy those confirmed negative for HCC by CT or MRI and those confirmed negative by ultrasound. The ultrasound-negative group will have a follow-up ultrasound 5 to 9 months after enrollment to reconfirm the absence of HCC. Blood samples collected will be used to study the performance of selected DNA methylation and protein markers for liver cancer diagnosis. Participants are screened based on medical history and recent imaging results to confirm eligibility. Assessments include blood collection and imaging studies, with additional follow-up imaging for some. Researchers will measure the sensitivity and specificity of the blood test within 1 to 9 months and investigate the effects of interfering substances, reference ranges, and sample stability. The study is observational, with no treatment administered, and is expected to continue through December 2028.

Multi-analyte Blood Test Clinical Trial