NCT05059665

Performance Evaluation (Sensitivity/Specificity) of HelioLiver Test for Detection of HCC

Specimen Collection for Multi-Analyte Blood-Test for Hepatocellular Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 290 (actual)
• Sponsor: Helio Genomics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

De-identified whole blood and serum samples are collected for the purpose of evaluating the performance (sensitivity/specificity) of the HelioLiver Test for the detection of hepatocellular carcinoma (HCC).

Detailed description

The purpose of this study is to define the performance characteristics (sensitivity and specificity) of the Helio Liver Test within a study population of subjects that have been diagnosed with liver cancer at various stages (I to IV) and for control subjects who have been confirmed to not have liver cancer by at least one imaging technique, such as ultrasound, MRI or CT. Control subjects will include patients who are at high-risk for liver cancer and have been recommended to undergo liver cancer surveillance, as well as patients who have non-HCC cancers to determine analytical specificity.

Conditions

• Hepatocellular Carcinoma by AJCC Stage

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Helio Liver Test	De-identified whole blood and serum samples are collected for the purpose of evaluating the performance (sensitivity/specificity) of the HelioLiver Test for the detection of hepatocellular carcinoma (HCC).

Timeline

• Start date: 2020-04-20
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2021-09-28
• Last updated: 2021-11-05

Locations

2 sites across 1 country: China