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

NCT05059665 | Completed

• 1 other identifier: LAM-2020-001
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 2

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).

Conditions

Hepatocellular Carcinoma by AJCC Stage

Outcome Measures

Primary Outcomes (2)

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

  performance evaluation (early stage, Stage I and II)

  15 months

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

  performance evaluation at all stages (I through IV)

  15 months

Study Arms (2)

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

Surveillance Subjects

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

Diagnostic Test: Helio Liver Test

Interventions

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).

HCC Subjects; Surveillance Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Years and Older (Adult, Older Adult)

You may not qualify if:

• None

Sponsors & Collaborators

• Helio Genomics: lead
• Laboratory for Advanced Medicine, Guangzhou: collaborator
• Helio Health Inc., Irvine, CA: collaborator

Study Sites (2)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510060, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and Plasma samples

Study Officials

• RIchard Van Etten, MD, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 28, 2021
• Study Start: April 20, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)