Performance Evaluation (Sensitivity/Specificity) of HelioLiver Test for Detection of HCC
- Conditions
- Hepatocellular Carcinoma by AJCC Stage
- Interventions
- Diagnostic Test: Helio Liver Test
- 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
- Arm && Interventions
Group Intervention Description HCC Subjects Helio Liver Test All subjects will be recently diagnosed with hepatocellular carcinoma as defined by at least one of the following criteria: * Subject has a ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance by MRI and/or CT. * Subject has a lesion of any size indicated to be HCC due to capsule appearance by 4 phase CT scan and/or multiphase contrast enhanced MRI. * Subjects with a suspicious lesion of less than 2 cm must have HCC confirmed by both MRI and CT. * Subject has a biopsy that is positive for HCC. * Diagnostic imaging by multiphasic MRI or CT indicates a suspicious lesion on the liver, which is subsequently confirmed to be HCC by another method (biopsy, or surgical pathology). Surveillance Subjects Helio Liver Test At-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC.
- 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 Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China