Liver CirrhosisCLiMBNCT03694600
Clinical Trial Multi-analyte Blood Test
An observational study of Liver Cirrhosis, run by Helio Genomics at 38 sites in United States.
Trial summary
This is a clinical trial designed to evaluate the performance of a multi-analyte blood test alone to ultrasound alone for the detection of HCC within a population that is at high risk for HCC due to liver cirrhosis. Read more about this study
- Who is it for?
- Ages 21 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Multi-analyte blood Test
- How many people
- 1,900 participants
- Where
- 38 sitesUnited States
- Study dates
- 4 Feb 2019to 30 Dec 2027
- 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 21 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The maximum study duration for any given subject participating in the trial will be approximately 21 months (includes Initial Surveillance Visit and Follow-Up Visits at 6 months, 12 months and 18 months). No study-related lab assessments, imaging or procedures shall be required for any subject after the Study Duration Period. Subject Eligibility Screening Period: 14 days Study Duration Period: Up to 21 months (includes Initial Surveillance Visit for all subjects and up to three Follow-Up Visits ONLY for subjects with indeterminant findings by diagnostic imaging) The maximum observational window for any subject enrolled in the study is expected to be approximately 21 months (for subjects with indeterminant findings by diagnostic imaging).
Who may be able to join
- Subject is age 21 to 84 (inclusive)
- Subject is able to read, comprehend and sign the Informed Consent Document
- Subject is willing and able to undergo liver cancer surveillance by ultrasound and the multi-analyte blood Test
- Subject is able and willing to undergo diagnostic imaging by multiphasic MRI with contrast according to the Study Protocol
- Subject has been diagnosed with liver cirrhosis by one or more of the following methods:
- Clinical diagnosis by blood analytes (APRI ≥ 1.5 or Bonacini cirrhosis discriminant score ≥ 8 or Lok index > 0.5)
Show all 9Show fewer
- Ultrasound and Elastography > 12.5 kPa (Vibration-controlled transient elastography, Point shear wave elastography, Two-dimensional shear wave ultrasound and transient elastography or Magnetic Resonance Elastography)
- Diagnostic imaging by CT or MRI (liver cirrhosis indicated on radiology report)
- Liver biopsy (liver cirrhosis indicated on pathology report)
Who cannot join
- The study investigator deems the subject's participation to be unsafe due to an underlying medical condition
- Subject has previously been diagnosed with a primary liver cancer or a non-liver cancer that has metastasized
- Subject has previously submitted a blood sample to Helio Health (HELIO) through a separate clinical protocol
- Subject is unable or unwilling to submit blood samples for testing, undergo ultrasound or undergo diagnostic imaging by multiphasic MRI with contrast as required for the Study Protocol
- Subject has any internal metallic device or fragment, including but not limited to: A pacemaker, artificial joint or valve, surgical clips, pins, plates, screws, wire mesh or shrapnel
- It is unsafe for the subject to receive an MRI contrast dye due to pregnancy or severe kidney disease
- Subject would not routinely be recommended for HCC surveillance
- Subject received an abdominal ultrasound or diagnostic imaging by MRI or CT to image the liver within the past 5 months
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Atlanta Gastroenterology
Atlanta, Georgia, 30308
Piedmont Research Institute
Atlanta, Georgia, 30309
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
AZ Liver Health (Chandler)
Chandler, Arizona, 85224
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45627
Liver Center of Texas
Dallas, Texas, 75234
Methodist Dallas Medical Center
Dallas, Texas, 79936
SouthTexas Research Institute
Edinburg, Texas, 78539
Texas Gastro Clinic
El Paso, Texas, 79936
Covenant Metabolic LLC
Fort Myers, Florida, 33012
University of Florida Clinical and Translational Science Institute
Gainesville, Florida, 32610
Konkord Research
Houston, Texas, 77065
Alliance Research Centers
Irvine, California, 92612
St Luke's Hospital of Kansas City
Kansas City, Kansas, 64111
Kansas City Research Institute (KCRI)
Kansas City, Missouri, 64131
University of South California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 40202
Loyola University Medical Center
Maywood, Illinois, 60153
Gastro One in Memphis
Memphis, Tennessee, 38104
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, 33136
Gastroenterology Group of Naples
Naples, Florida, 34102
Quality Medical
Nashville, Tennessee, 37211
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Digestive & Liver Disease Specialists (DLDS) - Norfolk
Norfolk, Virginia, 23502
Stanford University
Palo Alto, California, 94304
AZ Liver Health (Glendale, Peoria)
Peoria, Arizona, 85381
VA Richmond
Richmond, Virginia, 23249
Texas Liver Institute - American Research Corp.
San Antonio, Texas, 78215
Covenant Metabolics LLC
Sarasota, Florida, 34240
Harborview Medical Center (University of Washington)
Seattle, Washington, 98104
Liver Institute Northwest
Seattle, Washington, 98105
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
AZ Liver Health (Tucson)
Tucson, Arizona, 85712
Banner University Hospital (University of Arizona Tucson)
Tucson, Arizona, 85724
Impact Research Institute
Waco, Texas, 76710
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
About this study
Official title: Prospective Clinical Trial to Detect Liver Cancer Through Quantification of cfDNA Methylation in Blood Samples: A LAM Insight Trial Study
This is a clinical trial designed to evaluate the performance of a multi-analyte blood test alone to ultrasound alone for the detection of HCC within a population that is at high risk for HCC due to liver cirrhosis.
Read the detailed description
This multi-site, prospective study is designed to compare the sensitivity and specificity of a multi-analyte blood test alone to ultrasound alone for the detection of HCC within a population at high risk of HCC due to liver cirrhosis. Subjects will be enrolled until the pre-determined number of subjects are enrolled.
Subjects at high risk for developing HCC due to liver cirrhosis and who are eligible for liver cancer surveillance as determined by the patient's physician and who meet all inclusion and exclusion eligibility criteria as described in this protocol, will be invited to participate in this study. Subjects will then read, understand and sign the Informed Consent Form and the HIPAA Authorization Agreement for Medical Records Form.
For each subject upon enrollment, the following blood analytes will also be determined: creatinine, prothrombin time, bilirubin, blood platelet count, ALT, AST and ALP. The results of all clinical laboratory tests will be recorded by use of the subject's Case Report Form. Whole blood samples drawn for the multi-analyte blood test will be collected (according to the instructions provided with each sample collection kit) by using the multi-analyte Sample Collection, Stabilization and Shipping Kit, and shipped to a central LAM laboratory for testing. Samples will be assayed by laboratory technicians blinded to the results of any other testing. Within the same clinical visit as the blood draws (when possible), subjects will undergo conventional ultrasound to examine the liver. Every subject will then go on to diagnostic imaging by multiphasic MRI. The results of diagnostic imaging will primarily be scored by LI-RADS score and the number and size of any malignant lesions identified will be recorded. The images of all MRI, CT, or ultrasound will be saved and uploaded for evaluation by a blinded, centralized team of radiologists to confirm diagnosis. Any biopsy results or surgical pathology results that are generated for study subjects as part of current clinical practice will also be recorded.
Study procedures will consist of conventional ultrasound to examine the liver, providing blood samples for testing with the multi-analyte blood test and other conventional blood analytes, and diagnostic imaging by multiphasic MRI.
Upon enrolling in the study, subjects will commence the Initial Surveillance Visit (t=0 months). During the Initial Surveillance Visit, all enrolled subjects will undergo ultrasound to examine the liver and provide blood samples for the multi-analyte blood test and for determining conventional blood analytes. Every subject will then go on to diagnostic imaging by multiphasic MRI. The results of diagnostic imaging will primarily be scored by a Liver Reporting and Data System (LI-RADS) score. The data of all diagnostic imaging by MRI will be saved and uploaded for evaluation by a blinded, centralized team of radiologists, which will be used as the basis of the clinical truth for all subjects.
After the Initial Surveillance Visit (t=0 months), subjects with an indeterminant HCC finding by MRI (LI-RADS 3) will be recommended to up to three Follow-Up Visits (t=6 months, t=12 months, and t=18 months) to attempt to resolve the clinical truth for these subjects. Each Follow-Up Visit will consist of an ultrasound to examine the liver, providing blood samples for the multi-analyte blood test , as well as diagnostic imaging by multiphasic MRI.
Although not required by this clinical protocol, any biopsy or surgical pathology results, or any additional imaging (such as multiphasic CT) that are generated for study subjects as part of current clinical practice will also be recorded for each subject and the results shall be made available to the Sponsor if performed within 6 months of a scheduled Visit. Biopsy and surgical pathology results that indicate a malignancy will be used in place of diagnostic imaging as the clinical truth for each subject if performed within 6 months of a scheduled visit and prior to database lock.
All study-related procedures will occur during the Study Duration Period, which consists of the Initial Surveillance Visit for all subjects and up to three Follow-Up Visits for subjects with an initial indeterminant HCC finding (LI-RADS 3) by diagnostic imaging. After this Study Duration Period, no study related blood draws, imaging or procedures will occur for these subjects.
- Conditions
- Liver Cirrhosis
- Being tested
- Multi-analyte blood Test
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-analyte blood TestDiagnostic test
intended for the qualitative detection of DNA methylation profiles associated with hepatocellular carcinoma in cell-free DNA derived from patient whole blood specimens.
| Study group | Role | What they receive |
|---|---|---|
| men or women between 21-84 | Multi-analyte blood test alone versus ultrasound in subjects diagnosed with liver cirrhosis 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 vs ultrasound
The primary objective is to compare the performance (sensitivity and specificity) of the multi-analyte blood test alone to ultrasound alone for the detection of liver cancers within a high-risk population.
Measured: 1 month
Secondary outcomes (1)
Independent performance measure of sensitivity and specificity of a multi-analyte blood test vs ultrasound for the detection of liver cancer lesions that are ≤ 4 cm in diameter.
To compare the performance (sensitivity and specificity) of the multi-analyte blood test alone to ultrasound alone for the detection of liver cancer lesions that are ≤ 4 cm in diameter.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start4 Feb 2019
- Primary completion1 Feb 2023
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helio Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taggart, PhD, Study director, Helio Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694600
- Sponsor's protocol ID
- LAM-2018-01
- Acronym
- CLiMB
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2018
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Taggart DJ, Mahajan S, Gallant MA, Pinkoviezky I, Xu J, Sorg AJ, Roberts CC, Slinkov D, Gorospe EC, Mubarak A, Bhandari BR, Freilich B, Gunn N, Yang JD, Smith JH, Younes ZH, Cabrera R, Aguilar H, Samant H, Li W, Van Etten RA, Nguyen MH. A multi-analyte cfDNA-based blood test for early detection of hepatocellular carcinoma. J Hepatol. 2026 May 6:S0168-8278(26)00215-1. doi: 10.1016/j.jhep.2026.04.012. Online ahead of print.
PubMed 42102976
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
- Prospective Clinical Trial to Detect Liver Cancer Through Quantification of cfDNA Methylation in Blood Samples: A LAM Insight Trial Study
- ClinicalTrials.gov ID
- NCT03694600
- Acronym / sponsor ID
- CLiMB / LAM-2018-01
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- Helio GenomicsIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 3 Oct 2018 (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.
This is a clinical trial designed to evaluate the performance of a multi-analyte blood test alone to ultrasound alone for the detection of HCC within a population that is at high risk for HCC due to liver cirrhosis.
Detailed description
This multi-site, prospective study is designed to compare the sensitivity and specificity of a multi-analyte blood test alone to ultrasound alone for the detection of HCC within a population at high risk of HCC due to liver cirrhosis. Subjects will be enrolled until the pre-determined number of subjects are enrolled.
Subjects at high risk for developing HCC due to liver cirrhosis and who are eligible for liver cancer surveillance as determined by the patient's physician and who meet all inclusion and exclusion eligibility criteria as described in this protocol, will be invited to participate in this study. Subjects will then read, understand and sign the Informed Consent Form and the HIPAA Authorization Agreement for Medical Records Form.
For each subject upon enrollment, the following blood analytes will also be determined: creatinine, prothrombin time, bilirubin, blood platelet count, ALT, AST and ALP. The results of all clinical laboratory tests will be recorded by use of the subject's Case Report Form. Whole blood samples drawn for the multi-analyte blood test will be collected (according to the instructions provided with each sample collection kit) by using the multi-analyte Sample Collection, Stabilization and Shipping Kit, and shipped to a central LAM laboratory for testing. Samples will be assayed by laboratory technicians blinded to the results of any other testing. Within the same clinical visit as the blood draws (when possible), subjects will undergo conventional ultrasound to examine the liver. Every subject will then go on to diagnostic imaging by multiphasic MRI. The results of diagnostic imaging will primarily be scored by LI-RADS score and the number and size of any malignant lesions identified will be recorded. The images of all MRI, CT, or ultrasound will be saved and uploaded for evaluation by a blinded, centralized team of radiologists to confirm diagnosis. Any biopsy results or surgical pathology results that are generated for study subjects as part of current clinical practice will also be recorded.
Study procedures will consist of conventional ultrasound to examine the liver, providing blood samples for testing with the multi-analyte blood test and other conventional blood analytes, and diagnostic imaging by multiphasic MRI.
Upon enrolling in the study, subjects will commence the Initial Surveillance Visit (t=0 months). During the Initial Surveillance Visit, all enrolled subjects will undergo ultrasound to examine the liver and provide blood samples for the multi-analyte blood test and for determining conventional blood analytes. Every subject will then go on to diagnostic imaging by multiphasic MRI. The results of diagnostic imaging will primarily be scored by a Liver Reporting and Data System (LI-RADS) score. The data of all diagnostic imaging by MRI will be saved and uploaded for evaluation by a blinded, centralized team of radiologists, which will be used as the basis of the clinical truth for all subjects.
After the Initial Surveillance Visit (t=0 months), subjects with an indeterminant HCC finding by MRI (LI-RADS 3) will be recommended to up to three Follow-Up Visits (t=6 months, t=12 months, and t=18 months) to attempt to resolve the clinical truth for these subjects. Each Follow-Up Visit will consist of an ultrasound to examine the liver, providing blood samples for the multi-analyte blood test , as well as diagnostic imaging by multiphasic MRI.
Although not required by this clinical protocol, any biopsy or surgical pathology results, or any additional imaging (such as multiphasic CT) that are generated for study subjects as part of current clinical practice will also be recorded for each subject and the results shall be made available to the Sponsor if performed within 6 months of a scheduled Visit. Biopsy and surgical pathology results that indicate a malignancy will be used in place of diagnostic imaging as the clinical truth for each subject if performed within 6 months of a scheduled visit and prior to database lock.
All study-related procedures will occur during the Study Duration Period, which consists of the Initial Surveillance Visit for all subjects and up to three Follow-Up Visits for subjects with an initial indeterminant HCC finding (LI-RADS 3) by diagnostic imaging. After this Study Duration Period, no study related blood draws, imaging or procedures will occur for these subjects.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| men or women between 21-84 | – | Diagnostic Test: Multi-analyte blood TestMulti-analyte blood test alone versus ultrasound in subjects diagnosed with liver cirrhosis |
Who may qualify
- Ages
- 21 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The maximum study duration for any given subject participating in the trial will be approximately 21 months (includes Initial Surveillance Visit and Follow-Up Visits at 6 months, 12 months and 18 months). No study-related lab assessments, imaging or procedures shall be required for any subject after the Study Duration Period. Subject Eligibility Screening Period: 14 days Study Duration Period: Up to 21 months (includes Initial Surveillance Visit for all subjects and up to three Follow-Up Visits ONLY for subjects with indeterminant findings by diagnostic imaging) The maximum observational window for any subject enrolled in the study is expected to be approximately 21 months (for subjects with indeterminant findings by diagnostic imaging).
Key inclusion criteria (9 listed)
- Subject is age 21 to 84 (inclusive)
- Subject is able to read, comprehend and sign the Informed Consent Document
- Subject is willing and able to undergo liver cancer surveillance by ultrasound and the multi-analyte blood Test
- Subject is able and willing to undergo diagnostic imaging by multiphasic MRI with contrast according to the Study Protocol
- Subject has been diagnosed with liver cirrhosis by one or more of the following methods:
Key exclusion criteria (8 listed)
- The study investigator deems the subject's participation to be unsafe due to an underlying medical condition
- Subject has previously been diagnosed with a primary liver cancer or a non-liver cancer that has metastasized
- Subject has previously submitted a blood sample to Helio Health (HELIO) through a separate clinical protocol
- Subject is unable or unwilling to submit blood samples for testing, undergo ultrasound or undergo diagnostic imaging by multiphasic MRI with contrast as required for the Study Protocol
- Subject has any internal metallic device or fragment, including but not limited to: A pacemaker, artificial joint or valve, surgical clips, pins, plates, screws, wire mesh or shrapnel
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 Testintended for the qualitative detection of DNA methylation profiles associated with hepatocellular carcinoma in cell-free DNA derived from patient whole blood specimens. | Diagnostic test | men or women between 21-84 |
Primary outcome
Independent performance measure of sensitivity and specificity of a multi-analyte blood test vs ultrasound
Time frame: 1 month
The primary objective is to compare the performance (sensitivity and specificity) of the multi-analyte blood test alone to ultrasound alone for the detection of liver cancers within a high-risk population.
1 secondary outcome
Independent performance measure of sensitivity and specificity of a multi-analyte blood test vs ultrasound for the detection of liver cancer lesions that are ≤ 4 cm in diameter.
Time frame: 1 month
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.
- Derived from this study: PubMed 42102976Taggart DJ, Mahajan S, Gallant MA, Pinkoviezky I, Xu J, Sorg AJ, Roberts CC, Slinkov D, Gorospe EC, Mubarak A, Bhandari BR, Freilich B, Gunn N, Yang JD, Smith JH, Younes ZH, Cabrera R, Aguilar H, Samant H, Li W, Van Etten RA, Nguyen MH. A multi-analyte cfDNA-based blood test for early detection of hepatocellular carcinoma. J Hepatol. 2026 May 6:S0168-8278(26)00215-1. doi: 10.1016/j.jhep.2026.04.012. Online ahead of print.
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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.
Taggart, PhD study director
Helio Genomics
38 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, run by Helio Genomics at 38 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 9 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: under way, not looking for participants, 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 38 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?
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?
Independent performance measure of sensitivity and specificity of a multi-analyte blood test vs ultrasound (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694600, which also lists 1 linked publication.
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.