HELIO Liver Test Performance Study in China (HEPATIC)
- Conditions
- Hepatocellular Carcinoma and Liver Disease
- Interventions
- Diagnostic Test: Helio Liver Test
- Registration Number
- NCT05053412
- Lead Sponsor
- Helio Genomics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1556
- 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
-
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HCC diagnosed Stage 2 Helio Liver Test 150 stage 2 HCC diagnosed patients HCC diagnosed Stage 4 Helio Liver Test 50 stage 4 HCC diagnosed patients Control liver cancer surveillance subjects Helio Liver Test 500 patients total: 250 Subjects with liver cirrhosis, 250 subjects without liver cirrhosis HCC diagnosed Stage 1 (both A and B) Helio Liver Test 200 stage 1 (A and B) HCC diagnosed patients HCC diagnosed Stage 3 Helio Liver Test 100 stage 3 HCC diagnosed patients
- Primary Outcome Measures
Name Time Method evaluate sensitivity and specificity of Helio Liver Test enrollment period 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.
- Secondary Outcome Measures
Name Time Method secondary subset analysis for sensitivity enrollment period The sensitivity of the Helio Liver Test will be calculated based on cancer stage
secondary subset for sensitivity and specificity by severity of liver cirrhosis enrollment period Sensitivity and specificity by severity of liver cirrhosis (Child-Pugh score)
secondary subset analysis for sensitivity and specificity enrollment period The sensitivity and specificity of the Helio Liver Test will be evaluated based upon the underlying cause of liver cirrhosis
Trial Locations
- Locations (2)
People's Liberation Army General Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Beijing, China