NCT05053412

HELIO Liver Test Performance Study in China (HEPATIC)

Helio Liver Test Case-Controlled Performance Study in China (HEPATIC)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,556 (actual)
• Sponsor: Helio Genomics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not 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.

Conditions

• Hepatocellular Carcinoma and Liver Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Helio Liver Test	A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.

Timeline

• Start date: 2021-09-01
• Primary completion: 2024-03-01
• Completion: 2024-05-31
• First posted: 2021-09-22
• Last updated: 2024-08-02

Locations

2 sites across 1 country: China