Liver CirrhosisLIVER-1NCT05199259
Multi-analyte Blood Test Clinical Trial
An observational study of Liver Cirrhosis and Liver Cancer, run by Helio Genomics at 7 sites in United States.
Trial summary
The objective of this study is the acquisition of whole blood samples and serum samples from participants with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing Hepatocellular Carcinoma (HCC) surveillance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Liver Cancer, HCC
- What is being tested?
- Multi-analyte Blood Test
- How many people
- 1,200 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Mar 2022to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: The subjects will fall into two main groups, subjects diagnosed with HCC (HCC positive Group) or subjects without HCC (HCC negative Group). The HCC negative Group will be further divided into two sub-groups based on whether the absence of HCC has been determined using CT or MRI procedures (Sub-group 1) or ultrasound (Sub-group 2). Only the subjects in sub-group 2 will receive a confirmatory ultrasound approximately 6 months (between 5 to 7 months) after enrollment to confirm the absence of HCC ("6-month visit). This additional imaging study is necessary due to the low sensitivity of abdominal ultrasound to detect HCC lesions. The blood specimens will be shipped to a clinical diagnostic laborator
Who may be able to join
- Age 18 years or older.
- Males and Females.
- Having cirrhosis or meeting the AASLD guidelines for HCC
- surveillance.
- Clinically diagnosed with HCC or negative for HCC following disease
- surveillance.
Show all 10Show fewer
- HCC positive Group: Subject has a recent (within 6 months of enrollment) clinically diagnosed, untreated hepatocellular carcinoma as defined by at least one ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC.
- HCC negative Group: Non-cancer, at-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC, where the definitive lack of HCC within 3 months prior to enrollment has been verified by negative imaging, for HCC. No more than 200 subjects without cirrhosis can be enrolled in this group.
- Sub-Group 1 (approximately 450 subjects) - negative by CT or MRI (No lesion, LR-1 or LR-2)
- Sub-Group 2 (approximately 450 subjects) - negative by ultrasound
Who cannot join
- Subjects that are unwilling or unable to sign the Informed Consent Form will be excluded.
- Known cancer diagnosis of a cancer other than HCC within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
- Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
- Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC.
- Prior treatment with a DNA methyltransferase inhibitor such as with Vidaza (azacitidine) or Dacogen (decitabine)
- Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC).
Show all 12Show fewer
- IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection.
- Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
- Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
- Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
- For HCC negative subjects, patients with a prior diagnosis of HCC are also excluded.
- Subjects that are pregnant will be exclude
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
South Texas Research Institute
Edinburg, Texas, 78539
Site Manager, 956-284-6353, margaret.leal@southtexasresearchinstitute.com
Rashmee Patil, MD
- Recruiting
Texas Gastro Research
El Paso, Texas, 79936
Sub-I, 915-529-0009
Emmanuel Gorosphe, MD
- Recruiting
Gastroenterology and Liver Institute
Escondido, California, 02025
Yuri Guzman, MA, 760-690-2800
yguzman@giandliver.org
- Recruiting
UF Hepatology Research at CTRB
Gainesville, Florida, 32610
Lauren Morelli, CCRC, 352-273-9508, Lauren.Morelli@medicine.ufl.edu
Morelli
- Recruiting
Providence Facey Medical Foundation
Mission Hills, California, 91345
Clinical Research Associate, elyza.carvajal@providence.org
Dilpirt Bagga, MD
- Recruiting
Guardian Angel Research Center
Tampa, Florida, 33614
Study Coordinator, 813-877-5320, lporrod@gmail.com
Alejandro Diego, MD
- Recruiting
Impact Research Institute
Waco, Texas, 76710
Site Manager, 254-294-4780, mrichardson@impactresearchtx.com
Nadge Gunn, MD
About this study
Official title: Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma
The objective of this study is the acquisition of whole blood samples and serum samples from participants with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing Hepatocellular Carcinoma (HCC) surveillance. These samples will be used for research purposes to develop and validate the Helio multi-analyte blood test.
Read the detailed description
This study pertains to the collection of whole blood and serum specimens from participants undergoing Hepatocellular Carcinoma (HCC) surveillance. The participants will fall into two main groups, subjects diagnosed with HCC (HCC positive Group) or subjects without HCC (HCC negative Group).
The HCC negative Group will be further divided into two sub-groups based on whether the absence of HCC has been determined using CT or MRI procedures (Sub-group 1) or ultrasound (Sub-group 2). Only the participants in sub-group 2 will receive a confirmatory ultrasound approximately 6 months (between 5 to 9 months) after enrollment to confirm the absence of HCC (6-month visit). This additional imaging study is necessary due to the low sensitivity of abdominal ultrasound to detect HCC lesions.
Participants will be screened for eligibility to participate in the study based on their medical history and records. Participants with a recent confirmed Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the detection of Hepatocellular Carcinoma diagnosis of HCC (within 6 months of enrollment) may be enrolled in such way to ensure the cases are representative of the major liver disease etiologies in the surveillance population in the United States.
Specifically, the following causes of cirrhosis will be selected:
- Alcoholic steatohepatitis (ASH);
- Hepatitis B virus (HBV);
- Hepatitis C virus (HCV);
- Non-alcoholic fatty liver disease (NAFLD);
- Other genetic conditions that cause cirrhosis (i.e., hemochromatosis)
These blood samples will be used to perform various studies to determine the utility of selected DNA methylation and protein markers for the liver cancer diagnostic test.
- Conditions
- Liver Cirrhosis, Liver Cancer, HCC, Hepatocellular Carcinoma
- Being tested
- Multi-analyte Blood Test
- Medical subject headings
- Liver Cirrhosis, Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-analyte Blood TestDiagnostic test
A clinical diagnostic test based upon the detection and quantification of DNA methylation markers in cell-free DNA (cfDNA) isolated from plasma and of tumor-specific proteins isolated from serum.
| Study group | Role | What they receive |
|---|---|---|
| HCC positive Group | Multi-analyte blood test screen in participants with a recent confirmed untreated diagnosis of HCC by CT scan, MRI or biopsy. Receives: Diagnostic Test: Multi-analyte Blood Test | |
| HCC negative Group: Sub-Group 1 | Multi-analyte blood test screen in participants with a recent confirmed negative diagnosis of HCC by CT or MRI (No lesion, LR-1 or LR-2) Receives: Diagnostic Test: Multi-analyte Blood Test | |
| HCC negative Group: Sub-Group 2 | Multi-analyte blood test screen in participants with a recent confirmed negative diagnosis of HCC by ultrasound. Participants will be scheduled for a 6 month visit (at least 5 months but no more 9 months form enrollment) for a confirmatory ultrasound. Receives: Diagnostic Test: Multi-analyte Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent performance measure of sensitivity and specificity of a multi-analyte blood test
The primary objective is to measure the performance (sensitivity and specificity) the multi-analyte blood Test for the detection of liver cancers in high-risk particiapnats.
Measured: 1 - 9 months
Secondary outcomes (3)
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test for the detection of liver cancers within healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease.
Measured: 1 - 9 months
Ascertain Reference Range(s)
Ascertain reference range determination(s) for select CpG methylation sites
Measured: 1 - 9 months
Ascertain Sample Stability
Sample stability under various shipping conditions
Measured: 1 - 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Mar 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helio Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taggert, Study director, Helio Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199259
- Sponsor's protocol ID
- HELIO-2021-US-002
- Acronym
- LIVER-1
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2021
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05199259
- Acronym / sponsor ID
- LIVER-1 / HELIO-2021-US-002
- Conditions
- Liver Cirrhosis, Liver Cancer, HCC, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Helio GenomicsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Jan 2022 (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.
The objective of this study is the acquisition of whole blood samples and serum samples from participants with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing Hepatocellular Carcinoma (HCC) surveillance. These samples will be used for research purposes to develop and validate the Helio multi-analyte blood test.
Detailed description
This study pertains to the collection of whole blood and serum specimens from participants undergoing Hepatocellular Carcinoma (HCC) surveillance. The participants will fall into two main groups, subjects diagnosed with HCC (HCC positive Group) or subjects without HCC (HCC negative Group).
The HCC negative Group will be further divided into two sub-groups based on whether the absence of HCC has been determined using CT or MRI procedures (Sub-group 1) or ultrasound (Sub-group 2). Only the participants in sub-group 2 will receive a confirmatory ultrasound approximately 6 months (between 5 to 9 months) after enrollment to confirm the absence of HCC (6-month visit). This additional imaging study is necessary due to the low sensitivity of abdominal ultrasound to detect HCC lesions.
Participants will be screened for eligibility to participate in the study based on their medical history and records. Participants with a recent confirmed Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the detection of Hepatocellular Carcinoma diagnosis of HCC (within 6 months of enrollment) may be enrolled in such way to ensure the cases are representative of the major liver disease etiologies in the surveillance population in the United States.
Specifically, the following causes of cirrhosis will be selected:
- Alcoholic steatohepatitis (ASH);
- Hepatitis B virus (HBV);
- Hepatitis C virus (HCV);
- Non-alcoholic fatty liver disease (NAFLD);
- Other genetic conditions that cause cirrhosis (i.e., hemochromatosis)
These blood samples will be used to perform various studies to determine the utility of selected DNA methylation and protein markers for the liver cancer diagnostic test.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HCC positive Group | – | Diagnostic Test: Multi-analyte Blood TestMulti-analyte blood test screen in participants with a recent confirmed untreated diagnosis of HCC by CT scan, MRI or biopsy. |
| HCC negative Group: Sub-Group 1 | – | Diagnostic Test: Multi-analyte Blood TestMulti-analyte blood test screen in participants with a recent confirmed negative diagnosis of HCC by CT or MRI (No lesion, LR-1 or LR-2) |
| HCC negative Group: Sub-Group 2 | – | Diagnostic Test: Multi-analyte Blood TestMulti-analyte blood test screen in participants with a recent confirmed negative diagnosis of HCC by ultrasound. Participants will be scheduled for a 6 month visit (at least 5 months but no more 9 months form enrollment) for a confirmatory ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The subjects will fall into two main groups, subjects diagnosed with HCC (HCC positive Group) or subjects without HCC (HCC negative Group). The HCC negative Group will be further divided into two sub-groups based on whether the absence of HCC has been determined using CT or MRI procedures (Sub-group 1) or ultrasound (Sub-group 2). Only the subjects in sub-group 2 will receive a confirmatory ultrasound approximately 6 months (between 5 to 7 months) after enrollment to confirm the absence of HCC ("6-month visit). This additional imaging study is necessary due to the low sensitivity of abdominal ultrasound to detect HCC lesions. The blood specimens will be shipped to a clinical diagnostic laborator
Key inclusion criteria (10 listed)
- Age 18 years or older.
- Males and Females.
- Having cirrhosis or meeting the AASLD guidelines for HCC
- surveillance.
- Clinically diagnosed with HCC or negative for HCC following disease
Key exclusion criteria (12 listed)
- Subjects that are unwilling or unable to sign the Informed Consent Form will be excluded.
- Known cancer diagnosis of a cancer other than HCC within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
- Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
- Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC.
- Prior treatment with a DNA methyltransferase inhibitor such as with Vidaza (azacitidine) or Dacogen (decitabine)
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 |
|---|---|---|
| Multi-analyte Blood TestA clinical diagnostic test based upon the detection and quantification of DNA methylation markers in cell-free DNA (cfDNA) isolated from plasma and of tumor-specific proteins isolated from serum. | Diagnostic test | HCC negative Group: Sub-Group 1, HCC negative Group: Sub-Group 2, HCC positive Group |
Primary outcome
Independent performance measure of sensitivity and specificity of a multi-analyte blood test
Time frame: 1 - 9 months
The primary objective is to measure the performance (sensitivity and specificity) the multi-analyte blood Test for the detection of liver cancers in high-risk particiapnats.
3 secondary outcomes
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test
Time frame: 1 - 9 months
Ascertain Reference Range(s)
Time frame: 1 - 9 months
Ascertain Sample Stability
Time frame: 1 - 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
Related trials for Liver Cirrhosis
Not yet recruitingObservational study
Inflammatory and Neuroimmune Guided Investigation of Underlying Fatigue in Patients With Cirrhosis
Cirrhosis Alcoholic, Fatigue Symptom
RecruitingPhase 2
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
Primary Biliary Cholangitis
Active, not recruitingObservational study
AI-SC Multi-center Study
Liver Cirrhosis
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Not yet recruitingObservational study
Within-Session Repeatability of EUS-Guided Portal Pressure Gradient Measurement
Portal Hypertension, Chronic Liver Disease
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.
Taggert study director
Helio Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Liver Cancer, run by Helio Genomics at 7 sites in United States.
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 10 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations Manager, BSN, RN (626-350-0537, octavia@heliogenomics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent performance measure of sensitivity and specificity of a multi-analyte blood test (time frame: 1 - 9 months). 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 10 Jul 2026.