Hepatocellular Carcinoma by AJCC Stage
Conditions
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.
Interventions
DIAGNOSTIC_TESTHelio 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).
Sponsors
Laboratory for Advanced Medicine, Guangzhou
Helio Health Inc., Irvine, CA
Helio Genomics
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 Years and Older (Adult, Older Adult)
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for all stage HCCs | 15 months | performance evaluation at all stages (I through IV) |
Countries
China
Outcome results
None listed