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

Helio Genomics

Status: Completed

Conditions: Hepatocellular Carcinoma by AJCC Stage

Treatments: Diagnostic Test: Helio Liver Test

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05059665

LAM-2020-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 Years and Older (Adult, Older Adult)

Exclusion criteria

• None

Trial design

290 participants in 2 patient groups

HCC Subjects

Description:

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).

Treatment:

Diagnostic Test: Helio Liver Test

Surveillance Subjects

Description:

At-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC.

Treatment:

Diagnostic Test: Helio Liver Test