Clinical trial NCT05053412: HELIO Liver Test Performance Study in China (HEPATIC)
Official title: Helio Liver Test Case-Controlled Performance Study in China (HEPATIC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma and Liver Disease
Lead sponsor: Helio Genomics
Sponsor class: INDUSTRY
Collaborators: name: Helio Health Inc., Irvine, CA
First posted: 2021-09-22
Enrollment: 1556
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: evaluate sensitivity and specificity of Helio Liver Test
timeFrame: enrollment period
Secondary outcomes:
measure: secondary subset analysis for sensitivity
timeFrame: enrollment period
measure: secondary subset analysis for sensitivity and specificity
timeFrame: enrollment period
measure: secondary subset for sensitivity and specificity by severity of liver cirrhosis
timeFrame: enrollment period
Other outcomes:
Locations:
city: Beijing
country: China
facility: People's Liberation Army General Hospital
state: Beijing
city: Beijing
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
Study officials:
affiliation: University of California, Irvine
name: RIchard Van Etten, MD, PhD
role: STUDY_CHAIR
References: