Performance Evaluation (Sensitivity/Specificity) of HelioLiver Test for Detection of HCC
- Conditions
- Hepatocellular Carcinoma by AJCC Stage
- Registration Number
- NCT05059665
- Lead Sponsor
- Helio Genomics
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
- 18 Years and Older (Adult, Older Adult)
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for all stage HCCs 15 months performance evaluation at all stages (I through IV)
Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for early stage HCCs (Stage I and II) 15 months performance evaluation (early stage, Stage I and II)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University🇨🇳Guangzhou, Guangdong, China