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Multi-analyte Blood Test for Liver Conditions

This study is looking for people with liver cirrhosis, liver cancer (HCC), or those undergoing HCC surveillance. The goal is to collect blood samples to help develop and test a new diagnostic tool called the Multi-analyte Blood Test. This test looks for specific markers in your blood to detect liver cancer. Researchers want to see how well this blood test can accurately identify HCC (sensitivity) and correctly show when it's not present (specificity) over 1 to 9 months. You can join if you are 18 or older and have either a recent HCC diagnosis or are being monitored for HCC according to medical guidelines. The study is currently recruiting 1200 participants, but its exact status is unclear.

Study design
This is an observational study planning to enroll 1200 participants. It involves collecting whole blood and serum samples from two main groups: those with HCC and those without HCC.
What's involved
You will provide whole blood and serum samples. If you are in a specific subgroup without HCC, you might have an additional ultrasound approximately 6 months after enrollment.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to measure the test's performance over 1 to 9 months.

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NCT05199259

Multi-analyte Blood Test Clinical Trial

Recruiting
Not specifiedAges 18+Observational
Helio Genomics
~1,200 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Multi-analyte Blood Test

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Independent performance measure of sensitivity and specificity of a multi-analyte blood test
Measured over 1 - 9 months

Conditions

Liver Cirrhosis
Liver Cancer
HCC
Hepatocellular Carcinoma

Explore related trials

CirrhosisHepatocellular Carcinoma

Where it's being run

7 sites across 3 states
Texas3
California2
Florida2

Study leadership

  • Taggert · STUDY_DIRECTOR · Helio Health

Who to contact

Clinical Operations Manager, BSN, RN
[email protected]
626-350-0537
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

Exclusion

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).
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

What this trial measures

  • Independent performance measure of sensitivity and specificity of a multi-analyte blood test1 - 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.