HELIO Liver Test Performance Study in China (HEPATIC)

NCT ID: NCT05053412

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1556 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-05-31

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.

Conditions

Hepatocellular Carcinoma and Liver Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HCC diagnosed Stage 1 (both A and B)

200 stage 1 (A and B) HCC diagnosed patients

Helio Liver Test

Intervention Type: DIAGNOSTIC_TEST

A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.

HCC diagnosed Stage 2

150 stage 2 HCC diagnosed patients

Helio Liver Test

Intervention Type: DIAGNOSTIC_TEST

A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.

HCC diagnosed Stage 3

100 stage 3 HCC diagnosed patients

Helio Liver Test

Intervention Type: DIAGNOSTIC_TEST

A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.

HCC diagnosed Stage 4

50 stage 4 HCC diagnosed patients

Helio Liver Test

Intervention Type: DIAGNOSTIC_TEST

A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.

Control liver cancer surveillance subjects

500 patients total: 250 Subjects with liver cirrhosis, 250 subjects without liver cirrhosis

Helio Liver Test

Intervention Type: DIAGNOSTIC_TEST

A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.

Interventions

Helio Liver Test

A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• The subject has provided informed consent to participate in the study
• The subject is 18 to 75 years old (inclusive)

For subjects diagnosed with HCC, the subject must meet the following criteria:

• The subject must have active HCC at the time of the blood draw
• The subject has not undergone treatment for HCC

For subjects diagnosed with primary liver cancer, the subject has been recently diagnosed (within 3 months of enrollment) to have HCC by at least one of the following methods:

• Subject has a ≥1 cm lesion that is indicated to be HCC by MRI or CT due to exhibiting arterial phase hyperenhancement in combination with washout appearance
• Subject has a lesion of any size that is indicated to be HCC due to capsule appearance by 4 phase CT scan or multiphase contrast enhanced MRI
• 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) within 3 months from the blood draw

For subjects without liver cancer, the subject is confirmed NOT to have liver cancer by at least one of the following methods within 3 months of the blood draw

• Ultrasound result is negative for HCC or suspicious lesions
• Diagnostic imaging by multiphasic MRI or CT clearly indicates the subject does not have HCC

Exclusion Criteria

• Subject has previously been diagnosed with a primary liver cancer

• Subject has previously received any treatment for HCC prior to enrollment/blood sample collection, including: surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC
• Subject has undergone prior or current treatment for HCC with sorafenib, regorafenib, or other treatment indicated for HCC.
• Subject has received a cancer diagnosis within the past 5 years for any cancer (with the exceptions of basal cell or squamous cell skin cancers).
• Subject has received treatment for any cancer, including chemotherapy and/or radiation therapy, within 5 years prior to enrollment/sample collection.
• Subject have received IV contrast dye (for multiphasic CT or MRI) within 1 day [or 24 hours] of blood collection.
• Subject has undergone fine needle aspiration (FNA) of target pathology withing 3 days prior to blood collection.
• Subject has undergone a biopsy (other than FNA) of target pathology withing 7 days prior to blood collection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helio Health Inc., Irvine, CA

UNKNOWN

Sponsor Role: collaborator

Helio Genomics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

RIchard Van Etten, MD, PhD

Role: STUDY_CHAIR

University of California, Irvine

Locations

People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Beijing, , China

Countries

China

Other Identifiers

HELIO-2021-CH-001

Identifier Type: -

Identifier Source: org_study_id