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

November 4, 2021 updated by: Helio Genomics

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510060
        • The Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who have been clinically diagnosed with HCC, or are negative for HCC after regular surveillance, or have been clinically diagnosed with non-HCC cancers will be enrolled. Approximately 500 subjects will be enrolled.

Description

Inclusion Criteria:

  • 18 Years and Older (Adult, Older Adult)

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC Subjects

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).
Diagnostic test: Helio 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).
Surveillance Subjects
At-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC.
Diagnostic test: Helio 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
15 months
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)
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helio Genomics

Collaborators

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

Investigators

  • Principal Investigator: RIchard Van Etten, MD, PhD, University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

September 10, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAM-2020-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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