HELIO Liver Test Performance Study in China (HEPATIC)

NCT05053412 | Completed

• 1 other identifier: HELIO-2021-CH-001
• Study Type: observational
• Target: 1,556
• 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 and Liver Disease

Outcome Measures

Primary Outcomes (1)

• evaluate sensitivity and specificity of Helio Liver Test

  To evaluate the performance characteristics (sensitivity and specificity) of the Helio Liver Test within a population of subjects diagnosed with HCC or Control Subjects who are at high-risk of HCC due to a benign liver condition.

  enrollment period

Secondary Outcomes (3)

• secondary subset analysis for sensitivity

  enrollment period

• secondary subset analysis for sensitivity and specificity

  enrollment period

• secondary subset for sensitivity and specificity by severity of liver cirrhosis

  enrollment period

Study Arms (5)

HCC diagnosed Stage 1 (both A and B)

200 stage 1 (A and B) HCC diagnosed patients

Diagnostic Test: Helio Liver Test

HCC diagnosed Stage 2

150 stage 2 HCC diagnosed patients

Diagnostic Test: Helio Liver Test

HCC diagnosed Stage 3

100 stage 3 HCC diagnosed patients

Diagnostic Test: Helio Liver Test

HCC diagnosed Stage 4

50 stage 4 HCC diagnosed patients

Diagnostic Test: Helio Liver Test

Control liver cancer surveillance subjects

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

Diagnostic Test: Helio Liver Test

Interventions

Helio Liver Test 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; HCC diagnosed Stage 1 (both A and B); HCC diagnosed Stage 2; HCC diagnosed Stage 3; HCC diagnosed Stage 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• 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 will be enrolled. Approximately 1,000 subjects total will be enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helio Genomics: lead
• Helio Health Inc., Irvine, CA: collaborator

Study Sites (2)

People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Beijing, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Diseases

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases

Study Officials

• RIchard Van Etten, MD, PhD

  University of California, Irvine

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 22, 2021
• Study Start: September 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: May 31, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

CN (2)