Hepatocellular Carcinoma and Liver DiseaseHEPATICNCT05053412
HELIO Liver Test Performance Study in China (HEPATIC)
An observational study of Hepatocellular Carcinoma and Liver Disease, run by Helio Genomics at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma and Liver Disease
- What is being tested?
- Helio Liver Test
- How many people
- 1,556 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2021to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
People's Liberation Army General Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of Guangzhou Medical University
Beijing
About this study
Official title: Helio Liver Test Case-Controlled Performance Study in China (HEPATIC)
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).
Read the 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.
- Being tested
- Helio Liver Test
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helio Liver TestDiagnostic test
A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.
| Study group | Role | What they receive |
|---|---|---|
| HCC diagnosed Stage 1 (both A and B) | 200 stage 1 (A and B) HCC diagnosed patients Receives: Diagnostic Test: Helio Liver Test | |
| HCC diagnosed Stage 2 | 150 stage 2 HCC diagnosed patients Receives: Diagnostic Test: Helio Liver Test | |
| HCC diagnosed Stage 3 | 100 stage 3 HCC diagnosed patients Receives: Diagnostic Test: Helio Liver Test | |
| HCC diagnosed Stage 4 | 50 stage 4 HCC diagnosed patients Receives: Diagnostic Test: Helio Liver Test | |
| Control liver cancer surveillance subjects | 500 patients total: 250 Subjects with liver cirrhosis, 250 subjects without liver cirrhosis Receives: Diagnostic Test: Helio Liver Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: enrollment period
Secondary outcomes (3)
secondary subset analysis for sensitivity
The sensitivity of the Helio Liver Test will be calculated based on cancer stage
Measured: enrollment period
secondary subset analysis for sensitivity and specificity
The sensitivity and specificity of the Helio Liver Test will be evaluated based upon the underlying cause of liver cirrhosis
Measured: enrollment period
secondary subset for sensitivity and specificity by severity of liver cirrhosis
Sensitivity and specificity by severity of liver cirrhosis (Child-Pugh score)
Measured: enrollment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Mar 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma and Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helio Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Helio Health Inc., Irvine, CA
- Responsible party
- Sponsor
- Investigators
- RIchard Van Etten, MD, PhD, Study chair, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053412
- Sponsor's protocol ID
- HELIO-2021-CH-001
- Acronym
- HEPATIC
- Status last verified
- Jul 2024
- First submitted
- 16 Sep 2021
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helio Liver Test Case-Controlled Performance Study in China (HEPATIC)
- ClinicalTrials.gov ID
- NCT05053412
- Acronym / sponsor ID
- HEPATIC / HELIO-2021-CH-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,556 participants (actual)
- Lead sponsor
- Helio GenomicsIndustry (pharma, biotech, devices)
- Collaborators
- Helio Health Inc., Irvine, CA
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HCC diagnosed Stage 1 (both A and B) | – | Diagnostic Test: Helio Liver Test200 stage 1 (A and B) HCC diagnosed patients |
| HCC diagnosed Stage 2 | – | Diagnostic Test: Helio Liver Test150 stage 2 HCC diagnosed patients |
| HCC diagnosed Stage 3 | – | Diagnostic Test: Helio Liver Test100 stage 3 HCC diagnosed patients |
| HCC diagnosed Stage 4 | – | Diagnostic Test: Helio Liver Test50 stage 4 HCC diagnosed patients |
| Control liver cancer surveillance subjects | – | Diagnostic Test: Helio Liver Test500 patients total: 250 Subjects with liver cirrhosis, 250 subjects without liver cirrhosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- The subject has provided informed consent to participate in the study
- The subject is 18 to 75 years old (inclusive)
- 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:
Key exclusion criteria (8 listed)
- Subject has previously been diagnosed with a primary liver cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helio Liver TestA Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study. | Diagnostic test | 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 |
Primary outcome
evaluate sensitivity and specificity of Helio Liver Test
Time frame: 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.
3 secondary outcomes
secondary subset analysis for sensitivity
Time frame: enrollment period
secondary subset analysis for sensitivity and specificity
Time frame: enrollment period
secondary subset for sensitivity and specificity by severity of liver cirrhosis
Time frame: enrollment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RIchard Van Etten, MD, PhD study chair
University of California, Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Disease, run by Helio Genomics at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate sensitivity and specificity of Helio Liver Test (time frame: enrollment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.