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OpenTrials
Completed

NCT Number: NCT05059665

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

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).

Completed

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Key information

Conditions

Hepatocellular Carcinoma by AJCC Stage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 Years and Older (Adult, Older Adult)

Exclusion criteria

  • None

Treatment and study plan

Helio Liver Test

Diagnostic 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).

Primary outcomes

  1. Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for early stage HCCs (Stage I and II)

    Time frame: 15 months

    performance evaluation (early stage, Stage I and II)

  2. Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for all stage HCCs

    Time frame: 15 months

    performance evaluation at all stages (I through IV)

Sponsors and collaborators

Lead sponsor

Helio Genomics

Industry

Collaborators

  • Helio Health Inc., Irvine, CA
  • Laboratory for Advanced Medicine, Guangzhou

Registry information

Official study title

Specimen Collection for Multi-Analyte Blood-Test for Hepatocellular Carcinoma

Acronym: ENCORE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2021
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.