Hepatocellular Carcinoma by AJCC StageENCORENCT05059665
Performance Evaluation (Sensitivity/Specificity) of HelioLiver Test for Detection of HCC
An observational study of Hepatocellular Carcinoma by AJCC Stage, 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 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma by AJCC Stage
- What is being tested?
- Helio Liver Test
- Type of treatment
- Pill or oral medicine
- How many people
- 290 participants
- Where
- 2 sitesChina
- Study dates
- 20 Apr 2020to 1 Jul 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who have been clinically diagnosed with HCC, or are negative for HCC after regular surveillance, or have been clinically diagnosed with non-HCC cancers will be enrolled. Approximately 500 subjects will be enrolled.
Who may be able to join
- 18 Years and Older (Adult, Older Adult)
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510060
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Specimen Collection for Multi-Analyte Blood-Test for Hepatocellular Carcinoma
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, as well as patients who have non-HCC cancers to determine analytical specificity.
- Conditions
- Hepatocellular Carcinoma by AJCC Stage
- Being tested
- Helio Liver Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helio Liver TestDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| HCC Subjects | All subjects will be recently diagnosed with hepatocellular carcinoma as defined by at least one of the following criteria:
* Subject has a ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance by MRI and/or CT.
* Subject has a lesion of any size indicated to be HCC due to capsule appearance by 4 phase CT scan and/or multiphase contrast enhanced MRI.
* Subjects with a suspicious lesion of less than 2 cm must have HCC confirmed by both MRI and CT.
* 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). Receives: Diagnostic Test: Helio Liver Test | |
| Surveillance Subjects | At-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC. Receives: Diagnostic Test: Helio Liver Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for early stage HCCs (Stage I and II)
performance evaluation (early stage, Stage I and II)
Measured: 15 months
Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for all stage HCCs
performance evaluation at all stages (I through IV)
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start20 Apr 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma by AJCC StageStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helio Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratory for Advanced Medicine, Guangzhou, Helio Health Inc., Irvine, CA
- Responsible party
- Sponsor
- Investigators
- RIchard Van Etten, MD, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059665
- Sponsor's protocol ID
- LAM-2020-001
- Acronym
- ENCORE
- Status last verified
- Nov 2021
- First submitted
- 10 Sep 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimen Collection for Multi-Analyte Blood-Test for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05059665
- Acronym / sponsor ID
- ENCORE / LAM-2020-001
- Conditions
- Hepatocellular Carcinoma by AJCC Stage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Helio GenomicsIndustry (pharma, biotech, devices)
- Collaborators
- Laboratory for Advanced Medicine, Guangzhou, Helio Health Inc., Irvine, CA
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 28 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, as well as patients who have non-HCC cancers to determine analytical specificity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC Subjects | – | Diagnostic Test: Helio Liver TestAll subjects will be recently diagnosed with hepatocellular carcinoma as defined by at least one of the following criteria: * Subject has a ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance by MRI and/or CT. * Subject has a lesion of any size indicated to be HCC due to capsule appearance by 4 phase CT scan and/or multiphase contrast enhanced MRI. * Subjects with a suspicious lesion of less than 2 cm must have HCC confirmed by both MRI and CT. * 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). |
| Surveillance Subjects | – | Diagnostic Test: Helio Liver TestAt-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have been clinically diagnosed with HCC, or are negative for HCC after regular surveillance, or have been clinically diagnosed with non-HCC cancers will be enrolled. Approximately 500 subjects will be enrolled.
Key inclusion criteria (1 listed)
- 18 Years and Older (Adult, Older Adult)
Key exclusion criteria (1 listed)
- None
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 TestDe-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). | Diagnostic test | HCC Subjects, Surveillance Subjects |
Primary outcome
Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for early stage HCCs (Stage I and II)
Time frame: 15 months
performance evaluation (early stage, Stage I and II)
Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for all stage HCCs
Time frame: 15 months
performance evaluation at all stages (I through IV)
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 5 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma by AJCC Stage
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial
Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
RecruitingPhase 1/2
Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Liver Cancer
Advanced Hepatocellular Carcinoma, Cirrhosis
RecruitingPhase 4
Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
Advanced Biliary Tract Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer
Stage III Hepatocellular Carcinoma AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8
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 principal investigator
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 by AJCC Stage, 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 1 inclusion and 1 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 5 Nov 2021. 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 the performance (sensitivity/specificity) of the HelioLiver Test for early stage HCCs (Stage I and II) (time frame: 15 months). The study lists 2 primary outcomes in all. 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 5 Nov 2021.