MedDataX Logo

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

NCT ID: NCT05059665

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-20

Study Completion Date

2021-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma by AJCC Stage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Helio Liver Test

Intervention Type 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).

Surveillance Subjects

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

Helio Liver Test

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 Years and Older (Adult, Older Adult)

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laboratory for Advanced Medicine, Guangzhou

UNKNOWN

Sponsor Role collaborator

Helio Health Inc., Irvine, CA

UNKNOWN

Sponsor Role collaborator

Helio Genomics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

RIchard Van Etten, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LAM-2020-001

Identifier Type: -

Identifier Source: org_study_id